Continuous support for women during childbirth

Meghan A Bohren; G Justus Hofmeyr; Carol Sakala; Rieko K Fukuzawa; Anna Cuthbert

doi:10.1002/14651858.CD003766.pub6

. 2017 Jul 6;2017(7):CD003766. doi: 10.1002/14651858.CD003766.pub6

Continuous support for women during childbirth

Meghan A Bohren ^1,^✉, G Justus Hofmeyr ², Carol Sakala ³, Rieko K Fukuzawa ⁴, Anna Cuthbert ⁵

Editor: Cochrane Pregnancy and Childbirth Group

PMCID: PMC6483123 PMID: 28681500

Abstract

Background

Historically, women have generally been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has often become the exception rather than the routine.

Objectives

The primary objective was to assess the effects, on women and their babies, of continuous, one‐to‐one intrapartum support compared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influenced by:

1. Routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour, including: policies about the presence of support people of the woman's own choosing; epidural analgesia; and continuous electronic fetal monitoring.

2. The provider's relationship to the woman and to the facility: staff member of the facility (and thus has additional loyalties or responsibilities); not a staff member and not part of the woman's social network (present solely for the purpose of providing continuous support, e.g. a doula); or a person chosen by the woman from family members and friends;

3. Timing of onset (early or later in labour);

4. Model of support (support provided only around the time of childbirth or extended to include support during the antenatal and postpartum periods);

5. Country income level (high‐income compared to low‐ and middle‐income).

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 June 2017) and reference lists of retrieved studies.

Selection criteria

All published and unpublished randomised controlled trials, cluster‐randomised trials comparing continuous support during labour with usual care. Quasi‐randomised and cross‐over designs were not eligible for inclusion.

Data collection and analysis

Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We sought additional information from the trial authors. The quality of the evidence was assessed using the GRADE approach.

Main results

We included a total of 27 trials, and 26 trials involving 15,858 women provided usable outcome data for analysis. These trials were conducted in 17 different countries: 13 trials were conducted in high‐income settings; 13 trials in middle‐income settings; and no studies in low‐income settings. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (average RR 1.08, 95% confidence interval (CI) 1.04 to 1.12; 21 trials, 14,369 women; low‐quality evidence) and less likely to report negative ratings of or feelings about their childbirth experience (average RR 0.69, 95% CI 0.59 to 0.79; 11 trials, 11,133 women; low‐quality evidence) and to use any intrapartum analgesia (average RR 0.90, 95% CI 0.84 to 0.96; 15 trials, 12,433 women). In addition, their labours were shorter (MD ‐0.69 hours, 95% CI ‐1.04 to ‐0.34; 13 trials, 5429 women; low‐quality evidence), they were less likely to have a caesarean birth (average RR 0.75, 95% CI 0.64 to 0.88; 24 trials, 15,347 women; low‐quality evidence) or instrumental vaginal birth (RR 0.90, 95% CI 0.85 to 0.96; 19 trials, 14,118 women), regional analgesia (average RR 0.93, 95% CI 0.88 to 0.99; 9 trials, 11,444 women), or a baby with a low five‐minute Apgar score (RR 0.62, 95% CI 0.46 to 0.85; 14 trials, 12,615 women). Data from two trials for postpartum depression were not combined due to differences in women, hospitals and care providers included; both trials found fewer women developed depressive symptomatology if they had been supported in birth, although this may have been a chance result in one of the studies (low‐quality evidence). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, such as admission to special care nursery (average RR 0.97, 95% CI 0.76 to 1.25; 7 trials, 8897 women; low‐quality evidence), and exclusive or any breastfeeding at any time point (average RR 1.05, 95% CI 0.96 to 1.16; 4 trials, 5584 women; low‐quality evidence).

Subgroup analyses suggested that continuous support was most effective at reducing caesarean birth, when the provider was present in a doula role, and in settings in which epidural analgesia was not routinely available. Continuous labour support in settings where women were not permitted to have companions of their choosing with them in labour, was associated with greater likelihood of spontaneous vaginal birth and lower likelihood of a caesarean birth. Subgroup analysis of trials conducted in high‐income compared with trials in middle‐income countries suggests that continuous labour support offers similar benefits to women and babies for most outcomes, with the exception of caesarean birth, where studies from middle‐income countries showed a larger reduction in caesarean birth. No conclusions could be drawn about low‐income settings, electronic fetal monitoring, the timing of onset of continuous support or model of support.

Risk of bias varied in included studies: no study clearly blinded women and personnel; only one study sufficiently blinded outcome assessors. All other domains were of varying degrees of risk of bias. The quality of evidence was downgraded for lack of blinding in studies and other limitations in study designs, inconsistency, or imprecision of effect estimates.

Authors' conclusions

Continuous support during labour may improve outcomes for women and infants, including increased spontaneous vaginal birth, shorter duration of labour, and decreased caesarean birth, instrumental vaginal birth, use of any analgesia, use of regional analgesia, low five‐minute Apgar score and negative feelings about childbirth experiences. We found no evidence of harms of continuous labour support. Subgroup analyses should be interpreted with caution, and considered as exploratory and hypothesis‐generating, but evidence suggests continuous support with certain provider characteristics, in settings where epidural analgesia was not routinely available, in settings where women were not permitted to have companions of their choosing in labour, and in middle‐income country settings, may have a favourable impact on outcomes such as caesarean birth. Future research on continuous support during labour could focus on longer‐term outcomes (breastfeeding, mother‐infant interactions, postpartum depression, self‐esteem, difficulty mothering) and include more woman‐centred outcomes in low‐income settings.

Plain language summary

Continuous support for women during childbirth

What is the issue?

In the past, women have been cared for and supported by other women during labour and birth, and have had someone with them throughout, which we call ‘continuous support’. However, in many countries more women are giving birth in hospital rather than at home. This has meant continuous support during labour has become the exception rather than the norm. The aim of this Cochrane Review was to understand the effect of continuous support on a woman during labour and childbirth, and on her baby. We collected and analysed all relevant studies to answer this question (search date: October 2016).

Why is this important?

Research shows that women value and benefit from the presence of a support person during labour and childbirth. This support may include emotional support (continuous presence, reassurance and praise) and information about labour progress. It may also include advice about coping techniques, comfort measures (comforting touch, massage, warm baths/showers, encouraging mobility, promoting adequate fluid intake and output) and speaking up when needed on behalf of the woman. Lack of continuous support during childbirth has led to concerns that the experience of labour and birth may have become dehumanised.

Modern obstetric care frequently means women are required to experience institutional routines. These may have adverse effects on the quality, outcomes and experience of care during labour and childbirth. Supportive care during labour may enhance physiological labour processes, as well as women's feelings of control and confidence in their own strength and ability to give birth. This may reduce the need for obstetric intervention and also improve women's experiences.

What evidence did we find?

We found 26 studies that provided data from 17 countries, involving more than 15,000 women in a wide range of settings and circumstances. The continuous support was provided either by hospital staff (such as nurses or midwives), or women who were not hospital employees and had no personal relationship to the labouring woman (such as doulas or women who were provided with a modest amount of guidance on providing support). In other cases, the support came from companions of the woman's choice from her own network (such as her partner, mother, or friend).

Women who received continuous labour support may be more likely to give birth 'spontaneously', i.e. give birth vaginally with neither ventouse nor forceps nor caesarean. In addition, women may be less likely to use pain medications or to have a caesarean birth, and may be more likely to be satisfied and have shorter labours. Postpartum depression could be lower in women who were supported in labour, but we cannot be sure of this due to the studies being difficult to compare (they were in different settings, with different people giving support). The babies of women who received continuous support may be less likely to have low five‐minute Apgar scores (the score used when babies’ health and well‐being are assessed at birth and shortly afterwards). We did not find any difference in the numbers of babies admitted to special care, and there was no difference found in whether the babies were breastfed at age eight weeks. No adverse effects of support were identified. Overall, the quality of the evidence was all low due to limitations in study design and differences between studies.

What does this mean?

Continuous support in labour may improve a number of outcomes for both mother and baby, and no adverse outcomes have been identified. Continuous support from a person who is present solely to provide support, is not a member of the woman's own network, is experienced in providing labour support, and has at least a modest amount of training (such as a doula), appears beneficial. In comparison with having no companion during labour, support from a chosen family member or friend appears to increase women's satisfaction with their experience. Future research should explore how continuous support can be best provided in different contexts.

Summary of findings

Summary of findings for the main comparison. Continuous support compared to usual care (all trials) for women during childbirth.

Continuous support compared to usual care (all trials) for women during childbirth
Patient or population: women during childbirth  Setting: Hospital settings in Australia, Belgium, Botswana, Brazil, Canada, Chile, Finland, France, Greece, Guatamala, Iran, Mexico, Nigeria, South Africa, Thailand, Turkey, USA  Intervention: continuous support  Comparison: usual care (all trials)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
	Risk with usual care (all trials)	Risk with Continuous support
Spontaneous vaginal birth	Study population		Average RR 1.08  (1.04 to 1.12)	14369  (21 RCTs)	⊕⊕⊝⊝  LOW ^{1 2}
	679 per 1000	733 per 1000  (706 to 760)
Negative rating of/negative feelings about birth experience	Study population		Average RR 0.69  (0.59 to 0.79)	11133  (11 RCTs)	⊕⊕⊝⊝  LOW ^{1 2}
	177 per 1000	122 per 1000  (104 to 140)
Postpartum depression	Study population		‐	5716  (2 RCTs)	⊕⊕⊝⊝  LOW ^{1 3}	Both trials (Hodnett 2002; Hofmeyr 1991) were widely disparate in populations, the hospital conditions where they were conducted, and the type of support provider. We concluded that combining the trials data would not yield meaningful information. In both trials the direction of effect was the same. Hodnett 2002 used the Edinburgh Postnatal Depression Inventory and reported the frequencies of scores greater than 12. Hofmeyr 1991 used the Pitt Depression Inventory and reported scores indicating mild (less than 20), moderate (20 to 34), and severe (> 34) depressive symptomatology. We combined the frequencies of moderate and severe depressive symptomatology, since Pitt scores > 19 have been considered indicative of postpartum depression (Avan 2010). Continuous support resulted in a large reduction in depressive symptomology in Hofmeyr 1991 (RR 0.18, 95% CI 0.09 to 0.36). There was little or no difference in depressive symptomatology in Hodnett 2002 (RR 0.86, 95% CI 0.73 to 1.02)
	see comment	see comment
Admission to special care nursery	Study population		Average RR 0.97  (0.76 to 1.25)	8897  (7 RCTs)	⊕⊕⊝⊝  LOW ^{4 5}
	81 per 1000	79 per 1000  (62 to 101)
Exclusive or any breastfeeding at any time point, as defined by trial authors	Study population		Average RR 1.05  (0.96 to 1.16)	5584  (4 RCTs)	⊕⊕⊝⊝  LOW ^{1 6}
	601 per 1000	631 per 1000  (577 to 697)
Labour length	The mean length of labour in the usual care group ranged from 5.3 to 12.7 hours.	The mean length of labour in the continuous support group was on average 0.69 hours (1.04 to 0.34 hours) shorter		5429  (13 RCTs)	⊕⊕⊝⊝  LOW ^{1 2}
Caesarean birth	Study population		Average RR 0.75  (0.64 to 0.88)	15347  (24 RCTs)	⊕⊕⊝⊝  LOW ^{1 7}
	146 per 1000	109 per 1000  (93 to 128)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Date	Event	Description
31 October 2016	New search has been performed	Search updated and four new trials incorporated (Akbarzadeh 2014; Hans 2013; Isbir 2015; Safarzadeh 2012). A 'Summary of findings' table has been added for this update. Six new outcomes have been added.
31 October 2016	New citation required but conclusions have not changed	Four new trials included, but conclusions remain unchanged.
29 June 2013	New citation required but conclusions have not changed	Review updated. No new trials or data included.
29 June 2013	New search has been performed	Search updated. One new abstract identified and added to Characteristics of studies awaiting classification because it does not contain sufficient details to permit classification (Safarzadeh 2013).
12 July 2012	New citation required but conclusions have not changed	One new trial added (Yuenyong 2012). Data inadvertently omitted for one outcome (postpartum depression) from a prior trial (Hofmeyr 1991) have now been included. Minor clarifications to the text and changes to Results which did not substantively alter Conclusions.
14 June 2012	New search has been performed	Search updated and one new trial met inclusion criteria. One other trial report and seven new abstracts were found, one of which describes an ongoing study, and none of which contain sufficient details to permit classification.
31 December 2010	New search has been performed	Search updated. We evaluated and added new trials. We obtained additional information from trial authors. Other revisions included numerous changes to bring the entire Review up‐to‐date in terms of current methodological guidelines. We altered the acceptable follow‐up rate for long term outcomes, and we expanded the number of outcomes to be included in the planned subgroup analyses.
25 October 2010	New citation required but conclusions have not changed	New author joined the review team to update the review.
12 May 2008	Amended	Converted to new review format.
18 April 2007	New search has been performed	Search updated in February 2007. Two new trials identified. We excluded one (Dalal 2006) and included the other (Campbell 2006). The Results section was updated accordingly. With the exception of the outcome of labour length, there were no substantive changes in results or conclusions of the Review. Minor edits were made throughout. Additional text was added to the Discussion.
30 October 2006	New search has been performed	Search updated. One 'awaiting assessment' trial was assessed and included (Thomassen 2003).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Spontaneous vaginal birth	21	14369	Risk Ratio (M‐H, Random, 95% CI)	1.08 [1.04, 1.12]
2 Negative rating of/negative feelings about birth experience	11	11133	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.59, 0.79]
3 Postpartum depression	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
4 Admission to special care nursery	7	8897	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.76, 1.25]
5 Exclusive or any breastfeeding at any time point, as defined by trial authors	4	5584	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.96, 1.16]
6 Any analgesia/anaesthesia	15	12433	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.84, 0.96]
7 Regional analgesia/anaesthesia	9	11444	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.88, 0.99]
8 Synthetic oxytocin during labour	17	12833	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.91, 1.03]
9 Labour length	13	5429	Mean Difference (IV, Random, 95% CI)	‐0.69 [‐1.04, ‐0.34]
10 Postpartum report of severe labour pain	4	2456	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.83, 1.21]
11 Caesarean birth	24	15347	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.64, 0.88]
12 Instrumental vaginal birth	19	14118	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.85, 0.96]
13 Perineal trauma	4	8120	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.92, 1.01]
14 Delayed skin‐to‐skin contact, as defined by trial authors	1	212	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.64, 1.04]
15 Delayed initiation of breastfeeding (> 1 hour after birth, or as defined by trial authors)	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
16 Time from birth to initiation of breastfeeding	1	585	Mean Difference (IV, Fixed, 95% CI)	‐44.60 [‐47.63, ‐41.57]
17 Restricted mobility during labour, as defined by trial authors	1	6915	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [1.00, 1.05]
18 Low 5‐minute Apgar score	14	12615	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.46, 0.85]
19 Prolonged neonatal hospital stay	3	1098	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.42, 1.65]
20 Difficulty mothering	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
21 Low postpartum self‐esteem	1	652	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.77, 1.30]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Spontaneous vaginal birth	19	14218	Risk Ratio (IV, Random, 95% CI)	1.08 [1.04, 1.12]
1.1 Other support permitted	9	10889	Risk Ratio (IV, Random, 95% CI)	1.03 [1.00, 1.06]
1.2 Other support not permitted	10	3329	Risk Ratio (IV, Random, 95% CI)	1.11 [1.06, 1.17]
2 Negative rating of/negative feelings about birth experience	11	11178	Risk Ratio (IV, Random, 95% CI)	0.69 [0.60, 0.79]
2.1 Other support permitted	5	8639	Risk Ratio (IV, Random, 95% CI)	0.77 [0.60, 1.00]
2.2 Other support not permitted	6	2539	Risk Ratio (IV, Random, 95% CI)	0.63 [0.53, 0.74]
3 Postpartum depression	2		Risk Ratio (IV, Random, 95% CI)	Subtotals only
3.1 Other support permitted	1	5567	Risk Ratio (IV, Random, 95% CI)	0.86 [0.73, 1.02]
3.2 Other support not permitted	1	149	Risk Ratio (IV, Random, 95% CI)	0.18 [0.09, 0.36]
4 Admission to special care nursery	7	8897	Risk Ratio (IV, Random, 95% CI)	0.97 [0.76, 1.25]
4.1 Other support permitted	2	7328	Risk Ratio (IV, Random, 95% CI)	0.99 [0.82, 1.20]
4.2 Other support not permitted	5	1569	Risk Ratio (IV, Random, 95% CI)	0.87 [0.47, 1.61]
5 Exclusive or any breastfeeding at any time point, as defined by trial authors	3		Risk Ratio (IV, Random, 95% CI)	Subtotals only
5.1 Other support permitted	1	4559	Risk Ratio (IV, Random, 95% CI)	0.97 [0.92, 1.02]
5.2 Other support not permitted	2	804	Risk Ratio (IV, Random, 95% CI)	1.05 [0.98, 1.13]
6 Any analgesia/anaesthesia	14	12350	Risk Ratio (IV, Random, 95% CI)	0.90 [0.84, 0.96]
6.1 Other support permitted	7	9752	Risk Ratio (IV, Random, 95% CI)	0.97 [0.96, 0.99]
6.2 Other support not permitted	7	2598	Risk Ratio (IV, Random, 95% CI)	0.78 [0.61, 1.00]
7 Synthetic oxytocin during labour	15	12620	Risk Ratio (IV, Random, 95% CI)	0.97 [0.91, 1.04]
7.1 Other support permitted	5	9495	Risk Ratio (IV, Random, 95% CI)	0.99 [0.90, 1.10]
7.2 Other support not permitted	10	3125	Risk Ratio (IV, Random, 95% CI)	0.94 [0.85, 1.05]
8 Caesarean birth	22	15175	Risk Ratio (IV, Random, 95% CI)	0.78 [0.67, 0.91]
8.1 Other support permitted	11	11326	Risk Ratio (IV, Random, 95% CI)	0.91 [0.79, 1.04]
8.2 Other support not permitted	11	3849	Risk Ratio (IV, Random, 95% CI)	0.68 [0.52, 0.88]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Spontaneous vaginal birth	21	14441	Risk Ratio (IV, Random, 95% CI)	1.08 [1.04, 1.12]
1.1 Setting had routine EFM	8	9717	Risk Ratio (IV, Random, 95% CI)	1.07 [1.01, 1.13]
1.2 Setting did not have routine EFM	7	1913	Risk Ratio (IV, Random, 95% CI)	1.11 [1.06, 1.17]
1.3 Policy about routine EFM not known	6	2811	Risk Ratio (IV, Random, 95% CI)	1.09 [1.00, 1.18]
2 Negative rating of/negative views about birth experience	11	11154	Risk Ratio (IV, Random, 95% CI)	0.69 [0.60, 0.79]
2.1 Setting had routine EFM	4	7467	Risk Ratio (IV, Random, 95% CI)	0.72 [0.55, 0.94]
2.2 Setting did not have routine EFM	4	1710	Risk Ratio (IV, Random, 95% CI)	0.60 [0.49, 0.74]
2.3 Policy about routine EFM not known	3	1977	Risk Ratio (IV, Random, 95% CI)	0.84 [0.65, 1.08]
3 Postpartum depression	2		Risk Ratio (IV, Random, 95% CI)	Subtotals only
3.1 Setting had routine EFM	1	6915	Risk Ratio (IV, Random, 95% CI)	0.89 [0.75, 1.05]
3.2 Setting did not have routine EFM	1	149	Risk Ratio (IV, Random, 95% CI)	0.18 [0.09, 0.36]
4 Admission to special care nursery	7	8897	Risk Ratio (IV, Random, 95% CI)	0.97 [0.76, 1.25]
4.1 Setting had routine EFM	3	7740	Risk Ratio (IV, Random, 95% CI)	0.97 [0.84, 1.11]
4.2 Setting did not have routine EFM	3	729	Risk Ratio (IV, Random, 95% CI)	0.48 [0.15, 1.52]
4.3 Policy about routine EFM not known	1	428	Risk Ratio (IV, Random, 95% CI)	1.98 [0.76, 5.18]
5 Exclusive or any breastfeeding at any time point, as defined by trial authors	4		Risk Ratio (IV, Random, 95% CI)	Subtotals only
5.1 Setting had routine EFM	1	4559	Risk Ratio (IV, Random, 95% CI)	0.97 [0.92, 1.02]
5.2 Setting did not have routine EFM	2	804	Risk Ratio (IV, Random, 95% CI)	1.05 [0.98, 1.13]
5.3 Policy about routine EFM not known	1	221	Risk Ratio (IV, Random, 95% CI)	1.28 [1.02, 1.60]
6 Any analgesia/anaesthesia	14	12345	Risk Ratio (IV, Random, 95% CI)	0.90 [0.84, 0.96]
6.1 Setting had routine EFM	6	8580	Risk Ratio (IV, Random, 95% CI)	0.88 [0.79, 0.99]
6.2 Setting did not have routine EFM	6	2186	Risk Ratio (IV, Random, 95% CI)	0.90 [0.79, 1.04]
6.3 Policy about routine EFM not known	2	1579	Risk Ratio (IV, Random, 95% CI)	0.89 [0.80, 0.99]
7 Synthetic oxytocin during labour	17	12847	Risk Ratio (IV, Random, 95% CI)	0.97 [0.91, 1.03]
7.1 Setting had routine EFM	4	8340	Risk Ratio (IV, Random, 95% CI)	0.93 [0.78, 1.11]
7.2 Setting did not have routine EFM	8	1789	Risk Ratio (IV, Random, 95% CI)	0.80 [0.64, 1.01]
7.3 Policy about routine EFM not known	5	2718	Risk Ratio (IV, Random, 95% CI)	1.02 [0.97, 1.08]
8 Caesarean birth	24	15347	Risk Ratio (IV, Random, 95% CI)	0.75 [0.64, 0.88]
8.1 Setting had routine EFM	9	10123	Risk Ratio (IV, Random, 95% CI)	0.84 [0.71, 1.00]
8.2 Setting did not have routine EFM	9	2529	Risk Ratio (IV, Random, 95% CI)	0.59 [0.43, 0.81]
8.3 Policy about routine EFM not known	6	2695	Risk Ratio (IV, Random, 95% CI)	0.86 [0.56, 1.32]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Spontaneous vaginal birth	21	14468	Risk Ratio (IV, Random, 95% CI)	1.08 [1.04, 1.12]
1.1 Support people were hospital staff	9	10813	Risk Ratio (IV, Random, 95% CI)	1.05 [1.01, 1.09]
1.2 Support people were not hospital staff and were chosen by woman	6	1620	Risk Ratio (IV, Random, 95% CI)	1.04 [0.97, 1.11]
1.3 Support people were not hospital staff and not chosen by woman	6	2035	Risk Ratio (IV, Random, 95% CI)	1.15 [1.05, 1.26]
2 Negative rating of/negative feelings about birth experience	11	11178	Risk Ratio (IV, Random, 95% CI)	0.69 [0.60, 0.79]
2.1 Support people were hospital staff	4	8145	Risk Ratio (IV, Random, 95% CI)	0.87 [0.73, 1.03]
2.2 Support people were not hospital staff and not chosen by woman	3	1325	Risk Ratio (IV, Random, 95% CI)	0.65 [0.53, 0.80]
2.3 Support people were not hospital staff and were chosen by woman	4	1708	Risk Ratio (IV, Random, 95% CI)	0.58 [0.50, 0.67]
3 Postpartum depression	2		Risk Ratio (IV, Random, 95% CI)	Subtotals only
3.1 Support people were hospital staff	1	5567	Risk Ratio (IV, Random, 95% CI)	0.86 [0.73, 1.02]
3.2 Support people were not hospital staff and not chosen by woman	1	149	Risk Ratio (IV, Random, 95% CI)	0.17 [0.09, 0.33]
3.3 Support people were not hospital staff and were chosen by woman	0	0	Risk Ratio (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4 Admission to special care nursery	7	8897	Risk Ratio (IV, Random, 95% CI)	0.97 [0.76, 1.25]
4.1 Support people were hospital staff	3	7428	Risk Ratio (IV, Random, 95% CI)	0.99 [0.82, 1.20]
4.2 Support people were not hospital staff and not chosen by woman	2	829	Risk Ratio (IV, Random, 95% CI)	0.57 [0.17, 1.87]
4.3 Support people were not hospital staff and were chosen by woman	2	640	Risk Ratio (IV, Random, 95% CI)	1.38 [0.61, 3.14]
5 Exclusive or any breastfeeding at any time point, as defined by trial authors	4		Risk Ratio (IV, Random, 95% CI)	Subtotals only
5.1 Support people were hospital staff	1	4559	Risk Ratio (IV, Random, 95% CI)	0.97 [0.92, 1.02]
5.2 Support people were not hospital staff and not chosen by woman	3	1025	Risk Ratio (IV, Random, 95% CI)	1.11 [0.98, 1.26]
5.3 Support people were not hospital staff and were chosen by woman	0	0	Risk Ratio (IV, Random, 95% CI)	0.0 [0.0, 0.0]
6 Any analgesia/anaesthesia	14	12350	Risk Ratio (IV, Random, 95% CI)	0.90 [0.84, 0.96]
6.1 Support people were hospital staff	6	9152	Risk Ratio (IV, Random, 95% CI)	0.97 [0.96, 0.99]
6.2 Support people were not hospital staff and not chosen by woman	4	1790	Risk Ratio (IV, Random, 95% CI)	0.72 [0.47, 1.10]
6.3 Support people were not hospital staff and were chosen by woman	4	1408	Risk Ratio (IV, Random, 95% CI)	0.93 [0.86, 1.01]
7 Synthetic oxytocin during labour	17	12833	Risk Ratio (IV, Random, 95% CI)	0.97 [0.91, 1.03]
7.1 Support people were hospital staff	6	9561	Risk Ratio (IV, Random, 95% CI)	1.01 [0.93, 1.11]
7.2 Support people were not hospital staff and not chosen by woman	4	1081	Risk Ratio (IV, Random, 95% CI)	0.67 [0.43, 1.06]
7.3 Support people were not hospital staff and were chosen by woman	7	2191	Risk Ratio (IV, Random, 95% CI)	0.99 [0.96, 1.01]
8 Caesarean birth	24	15347	Risk Ratio (IV, Random, 95% CI)	0.75 [0.64, 0.88]
8.1 Support people were hospital staff	9	10786	Risk Ratio (IV, Random, 95% CI)	0.94 [0.84, 1.05]
8.2 Support people were not hospital staff and not chosen by woman	9	2502	Risk Ratio (IV, Random, 95% CI)	0.61 [0.45, 0.83]
8.3 Support people were not hospital staff and were chosen by woman	6	2059	Risk Ratio (IV, Random, 95% CI)	0.76 [0.50, 1.17]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Exclusive or any breastfeeding at any time point, as defined by trial authors	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
1.1 Intrapartum period only	3	5363	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.94, 1.09]
1.2 Extended model (antenatal, intrapartum, postnatal)	1	221	Risk Ratio (M‐H, Random, 95% CI)	1.28 [1.02, 1.60]

Methods	RCT
Participants	Pregnant women aged 18 to 35 years, with a singleton, term pregnancy, and healthy fetal membranes. No history of medical, surgical, or mental problems and no special problems during pregnancy. The participants’ uterine contractions started spontaneously and, at admission, the contractions occurred every 5 to 10 minutes and cervical dilatation was 3 to 4 cm
Interventions	The study was conducted in Shoushtari Hospital, Iran in 2012. In the supportive care group (N = 50), the doula was constantly beside the mother from the beginning of the mother’s maternity ward admission (beginning of the active phase of labour at 3 to 4 cm cervical dilatation) to the end of the second stage of labour. Supportive measures classified into psychological and emotional, educational, and physical categories were offered to the mother. Psychological and emotional support included touching, empathy, compassion, encouraging the mother to continue cooperation in the labour process, reassurance, taking mother’s hands, maintaining eye contact, creating a sense of trust and confidence, continuous talking, and reduction of fear during labour. Educational support included informing the mother about the natural process of childbirth and answering her questions. Finally, physical support included cooling the mother, satisfying her hunger and thirst, and helping her change the positions in various stages of labour. The control group (N = 50) received the department’s routine care and underwent no interventions
Outcomes	Pain assessment (before and after intervention) using the VAS. VAS is a scale numerated from 0 to 10 with 0, 1 to 3, 4 to 6, 7 to 9, and 10 representing no, mild, moderate, severe, and the worst possible pain. Mode of delivery (CS, VD)
Notes	For all women who received doula care in the intervention group, the doula was one researcher. Unknown if companions were typically permitted on the ward, if continuous EFM was used routinely, or if epidural anaesthesia was available Dates of study: 2012 Funding: The study was financially supported by the Research Center for Traditional Medicine and History of Medicine and the Research Vice‐Chancellor of Shiraz University of Medical Sciences, Shiraz, Iran. Conflicts of interest: The authors declare that they have no known conflict of interests.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Akbarzadeh 2015 and Masoudi 2014 specify the process of selecting blocks, "the subjects were selected through simple random sampling and were divided into supportive care, acupressure, and control groups using stratified block randomisation. In doing so, a number was randomly selected from the table of random numbers and the researcher moved toward the right or left column or row and wrote the 5 digit numbers down. Since the participants were divided into 3 groups in this study, 3‐therapy method was used and classification was performed as follows: A: supportive care group, B: acupressure group, and C: control group. Accordingly, ABC: 1, ACB: 2, BAC: 3, BCA: 4, CAB: 5, and CBA: 6. It should be noted that numbers 0, 7, and 9 were ignored".
Allocation concealment (selection bias)	Unclear risk	Unclear if central randomisation, sequentially numbered/opaque containers were used during allocation
Blinding of participants and personnel (performance bias)   All outcomes	High risk	There is no mention of blinding of participants or personnel throughout this study, but blinding of participants and personnel is not possible
Blinding of outcome assessment (detection bias)   All outcomes	High risk	The study data were collected using interview form (including demographic information, history of pregnancy, familial status, and pregnancy information), observation form (including evaluation of uterine contractions, fetal heart rate, labour progress, and delivery outcome), and VAS. VAS is a scale numerated from 0 to 10 with 0, 1 to 3, 4 to 6, 7 to 9, and 10 representing no, mild, moderate, severe, and the worst possible pain. High risk of bias for pain reporting in the intervention‐supportive care group, as pain is a subjective and self‐reported outcome and women would know whether they were in the intervention or control group. Low risk of bias for mode of delivery, as was assessed using observation and mode of delivery is an objective outcome
Incomplete outcome data (attrition bias)   All outcomes	Low risk	From tables 1 and 2, it appears that there was no missing data from either outcome in the intervention or control group
Selective reporting (reporting bias)	Low risk	Important outcomes were included across the 3 references for this study
Other bias	Low risk	Low risk of other bias

Methods	RCT
Participants	212 nulliparous women in active labour at term (105 support group, 107 control group) at a University‐affiliated hospital in São Paulo, Brazil. To be eligible a companion of the woman's choosing had to be available. 49.5% of the companions were present at enrolment and the others were phoned and asked to come to the hospital (4 failed to make it before delivery)
Interventions	Support was 'presence of a chosen companion during labour and delivery'. 'The companions received verbal and written information on the activities involved in providing support, expected behaviour when confronted with signs of tiredness, anxiety, concern, crying, screaming and/or the woman's feelings of inability to cope, compliance with regulations and the possibility of requesting information from staff'. in 47.6% of the sample the woman's companion was her partner, for 29.5% it was her mother. The control group received usual care where a companion during labour and delivery was not permitted. For both groups labour and delivery care was provided 'according to the routine protocol including active management of labour (early amniotomy, use of oxytocin, intermittent EFM and systematic analgesia)'
Outcomes	Satisfaction with labour and delivery, perinatal and breastfeeding outcome in the 12 hours post delivery
Notes	All women in labour at this hospital received epidural analgesia as a routine practice. Therefore, we did not include epidural analgesia data in the review. EFM was not used routinely Dates of study: February 2004 ‐ March 2005 Funding: financial support of CAPES (Coordination of improvement for graduated personnel), Brazil. Conflicts of interest: The author(s) declare that they have no competing interests.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	'Computer generated sequence of random numbers.'
Allocation concealment (selection bias)	High risk	'Individual assignment numbers were all placed in an opaque container to assure the concealment. The eligible women who had agreed to participate selected one of the numbers once, and were therefore allocated to either intervention group or control according to the list.' This process was open to selection bias as women could have re‐picked another number from the container. No audit process is possible with this system of randomisation
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, clinicians and researchers were aware of group allocation
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Data collection by the author, who knew group allocation. Higher risk of bias for the "satisfaction" outcomes, compared to the clinical outcomes
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data were collected and in‐hospital questionnaires were completed for 100% of sample
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	3 trials are reported separately in 1 publication. Participants were nulliparous, healthy, in spontaneous labour, term, with singleton vertex presentations.  Trial in Belgium: N = 264 (133 permanent support; 131 control)
Interventions	Permanent presence of a midwife compared to varying degrees of presence. Fathers were allowed to be present
Outcomes	Oxytocin, epidural analgesia, labour length, mode of birth, Apgar scores, mothers' views of their experiences
Notes	Epidural analgesia was available and it is not known whether EFM was used routinely Dates of study: not clear, trials ended in 1992 Funding: not clear ‐ "European Community concerted action". Conflicts of interest: Not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Women were 'randomly assigned'. The envelopes were prepared by the co‐ordinating centre. No mention of the process of sequence generation
Allocation concealment (selection bias)	Unclear risk	Sealed envelopes. No mention if they were opaque or consecutively numbered. The process of how the envelopes were opened was not described
Blinding of participants and personnel (performance bias)   All outcomes	High risk	No information provided about blinding of participants or personnel, but blinding of participants and personnel is not possible
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	No information provided about blinding of outcome assessors
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Completion rate for medical record data and in‐hospital questionnaire were 99.2% and 91.0% respectively
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	See Bréart ‐ Belgium 1992
Participants	See Bréart ‐ Belgium 1992   Trial in France: N = 1320 (656 continuous support; 664 control)
Interventions	See Bréart ‐ Belgium 1992. Fathers were allowed to be present
Outcomes	See Bréart ‐ Belgium 1992
Notes	Epidural analgesia was available and it is unknown whether EFM was routine Dates of study: not clear, trials ended in 1992 Funding: not clear ‐ "European Community concerted action". Conflicts of interest: Not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Women were 'randomly assigned'. The envelopes were prepared by the co‐ordinating centre. No mention of the process of sequence generation
Allocation concealment (selection bias)	Unclear risk	Sealed envelopes. No mention if they were opaque or consecutively numbered. The process of how the envelopes were opened was not described
Blinding of participants and personnel (performance bias)   All outcomes	High risk	No information provided about blinding of participants or personnel, but blinding of participants and personnel is not possible
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	No information provided about blinding of outcome assessors
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Completion rate for medical record data and in‐hospital questionnaire was > 95%. There were some discrepancies in the total number enrolled. Two reports show 656 in the permanent support group and 664 in the control group for a total of 1320. The table of results in 1 report shows 654 in the permanent support and 666 in control. The in‐hospital questionnaire results are shown for 654 and 664 women (total 1318) but the authors state this is 95% of the sample, meaning the total is 1386. The N reported for each outcome were used in the data tables in this review
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	600 nulliparous, low‐income, under‐insured pregnant women (300 doula group, 300 control group) booked for delivery at a hospital in New Jersey, USA were enrolled between 12 and 38 weeks' gestation. They were considered low risk, with no contraindications to labour and had a female friend or relative willing to act as their lay doula. The doula was in addition to support people of their own choosing
Interventions	Intervention: continuous support by a female friend or relative who had 2, 2‐hour sessions about labour support. The training sessions were conducted for nearly all of the lay caregivers when the participants were 34 to 36 weeks' gestation. Control group: support people of their own choosing
Outcomes	Labour length, epidural analgesia, oxytocin augmentation, cervical dilation at epidural insertion, length of second stage labour, caesarean birth, 1‐min Apgar score > 6, 5‐min Apgar score > 6, delayed initiation of breastfeeding
Notes	Epidural analgesia was available and EFM was used routinely Dates of study: enrolment took place between 1998 and 2002 Funding: Johnson & Johnson provided a small stipend to complete the data analysis. "Johnson & Johnson did not influence the design and conduct of the study or the analysis and interpretation of the data." Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer generated randomisation scheme"
Allocation concealment (selection bias)	Low risk	Consecutively‐numbered, sealed opaque envelopes contained treatment assignments. After obtaining consent, a research assistant opened the next envelope. It was unclear whether the research assistant enrolling the woman was the same one that opened the envelope
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Labour room staff, participants, and the participant's caregivers were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Medical record abstraction was done by the author who was not blinded. The 6‐week questionnaire data collection was not blinded
Incomplete outcome data (attrition bias)   All outcomes	High risk	Medical record information was completed for 97.7% of the sample (82.3% in the intervention group and 94.3% in the control group). The differential rates are due to withdrawals from the intervention group for doula related reasons (incomplete training and not being present during labour). The 6‐week questionnaire was completed for 82.3% of the sample. Only those women included in the study at delivery had the opportunity to complete the questionnaire and thus the differential completion rate between groups remained (76.3% in the intervention group and 88.3% in the control group). The differential withdrawals could introduce selection bias
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Unclear risk	The training of the doulas giving the intervention was done by the research assistant, who was herself a doula. This same research assistant enrolled all study participants

Methods	RCT
Participants	34 women (primigravidas and multigravidas) at 26 to 37 weeks' gestation in 2 Texas hospitals (20 to supported group and 14 to usual care). They were in early, uncomplicated preterm labour
Interventions	Intervention: support provided by a Lamaze childbirth preparation instructor. Support included continuous presence, acting as a liaison with hospital staff, providing information, and teaching relaxation and breathing measures. Usual care: intermittent nursing care. Family members allowed to be present
Outcomes	Fetal distress, caesarean birth, artificial oxytocin, labour length, Apgar scores, neonatal intensive care
Notes	Not stated if epidural analgesia was available or if EFM was used routinely Dates of study: accepted to journal 1987. Exact dates not reported Funding: not reported. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomly assigned." No further details provided
Allocation concealment (selection bias)	Unclear risk	Admitting nurse telephoned research assistant to obtain treatment allocation. No details about whether the research assistant had foreknowledge of the treatment allocation scheme
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, participant's family members and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Medical record information collected by 'research assistants who did not know the group membership of the women'. However, medical records written by staff who were not blinded to group assignment
Incomplete outcome data (attrition bias)   All outcomes	High risk	Withdrawals occurred before analysis (6 (30%) in support group and 3 (21%) in control). This resulted in a follow‐up rate of 73.5%. The withdrawals were done differentially in the support group, i.e. some women were withdrawn because of an event that occurred before the support person arrived. Women in the control group with the same event were not withdrawn. We were able to re‐create the original study groups for 1 outcome only, caesarean birth, and therefore it was included in the analysis table
Selective reporting (reporting bias)	Unclear risk	No outcomes were stated a priori
Other bias	Low risk	No other sources of bias noted

Methods	RCT, stratified by induced or spontaneous labour at trial entry
Participants	992 nulliparous women at term (499 to continuous support and 493 to control), cephalic fetal presentation, cervical dilatation < 5 cm, in a hospital in Perth, Western Australia
Interventions	Group 1: continuous physical and emotional support by midwifery staff, and women were encouraged to use pharmacologic and nonpharmacologic alternatives to epidural analgesia.  Group 2: continuous midwifery support was not provided and women were encouraged to have epidural analgesia as their primary method of pain relief in labour
Outcomes	Labour length (expressed as median and interquartile range), epidural analgesia, mode of delivery, 5 min Apgar score < 7, arterial cord pH
Notes	The stated purpose was to compare the effects of intrapartum analgesic techniques on labour outcomes. Continuous midwifery support was conceptualised as an analgesic technique. Both groups had access to opioids and nitrous oxide. No data were presented about the number of women who used no pharmacologic analgesia. Because the type of analgesia used was a measure of compliance rather than an outcome, no data on analgesic outcomes are included in this review. It was not stated if other support person was allowed. epidural analgesia was available and EFM was used routinely Dates of study: May 1997 ‐ October 1999 Funding: The conduct of this research was supported by NH&MRC Grant 970076. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details about how the blocks of treatment allocations were produced
Allocation concealment (selection bias)	Unclear risk	Randomisation on presentation in the labour and delivery unit, "by selection from a blocked group of eight sealed opaque envelopes, replenished from blocks of 12". No further details about process
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Blinding of participants and personnel is not possible
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Unclear if the outcome assessor was blinded to group assignment
Incomplete outcome data (attrition bias)   All outcomes	Low risk	There was 100% follow‐up for medical record data and in‐hospital survey. A 6‐month questionnaire was completed by 64.7% of the sample and these data were not used
Selective reporting (reporting bias)	Low risk	All main outcomes were reported. Effects on breastfeeding were not analysed by treatment group and thus the results could not be included in the review
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	413 women admitted to an intrapartum unit at a tertiary care teaching hospital in Montreal, Canada, were randomly allocated to experimental (N = 209) or control (N = 204) groups. All but 3 in the experimental group and 6 in the control group were accompanied by a spouse, relative or friend during labour. All participants were nulliparous, with singleton fetuses, > 37 weeks' gestation, and in labour
Interventions	Experimental: One‐to‐one nursing care from randomisation until 1 hour post birth. Care was provided by on‐call nurses who were hired specifically for the study and had received a 30‐hour training program and quarterly refresher workshops. The training program included critical reviews of the literature concerning the effects of intrapartum medical and nursing practices, as well as discussions of stress and pain management techniques. The nurse provided the usual nursing care plus physical comfort, emotional support, and instruction on relaxation and coping techniques. The nurse took meal breaks and brief rest breaks. Women in the comparison group received usual nursing care by the regular unit staff, consisting of intermittent support and monitoring
Outcomes	Caesarean birth, caesarean birth for cephalopelvic disproportion or failure to progress, post‐randomisation artificial oxytocin augmentation, post‐randomisation analgesia/anaesthesia, instrumental vaginal delivery (forceps or vacuum extraction), NICU admission, perineal trauma, mean duration of labour post‐randomisation, postpartum urinary catheterisation
Notes	The participants had been admitted to the unit for an average of 5 hours (SD = 4 hours) prior to randomisation. 36 women in the experimental group and 41 in the control group had epidural analgesia prior to randomisation. 55 women in the experimental group and 45 in the control group had intravenous oxytocin augmentation of labour prior to randomisation. Mean duration of labour post‐randomisation was 9.2 hours (SD = 4.3). Epidural analgesia was available but it was not stated if EFM was used routinely Dates of study: not clear Funding: This project was supported by the Fonds de la recherche en sante' du Que'bec (FRSQ), a research funding agency of the government of Quebec, Montreal, Quebec, Canada. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomized using a list of computer generated random numbers."
Allocation concealment (selection bias)	Low risk	"Randomized in blocks of eight... Group assignments were placed in sequentially numbered, sealed, opaque envelopes."
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, participants' family members, and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Outcome data not collected by clinical staff, self‐administered questionnaires were used, and data collectors reviewed nurses' notes after "most" other data from medical records was collected
Incomplete outcome data (attrition bias)   All outcomes	Low risk	100% follow‐up
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	248 pregnant women (124 control group, 124 doula group) attending 2 affiliated prenatal clinics, who were aged under 22 years, less than 34 weeks' gestation, and not planning to move from the area or give their baby up for adoption
Interventions	Intervention: doula support from a community doula service during pregnancy through 3 months postpartum, as well as usual care services. 4 doulas were trained as part of the program, from the communities surrounding the hospital, and participated in a 10 week training session. Doulas initiated contact with participants, and scheduled weekly visits throughout her pregnancy through 3 months postpartum, and participants were encouraged to call the doula when they went into labour. Control: usual prenatal healthcare and social services
Outcomes	Parent‐child interactions: reported through 2 parenting constructs (maternal sensitive responsiveness and maternal encouragement and guidance) and 1 child construct (positive involvement with parent), as measured through video recordings of parent‐child interactions at 4, 12 and 24 months of age using the Parent‐Child Observation Guide. Parenting attitudes: reported through the Adult‐Adolescent Parenting Inventory at 4 months of age. Parenting stress: reported through the Parenting Stress Inventory‐Short Form at 4, 12 and 24 months of age. Breastfeeding duration
Notes	For all women who received doula care in the intervention group, the doula was 1 of 4 study doulas. Unknown if companions were typically permitted on the ward, if continuous EFM was used routinely, or if epidural anaesthesia was available. Women in the doula group were encouraged to contact their doula at the start of their labour, but only 101 women (81.5%) in the doula group had the doula in attendance at the birth. The authors report that the most common reasons for doula absence at the birth were: (1) short labours; and (2) failed communication between the woman and the doula. In the analysis, it is not possible to determine which women in the doula group had a doula present with them during birth Dates of study: 3 year period, dates not clear Funding: This research was supported by Grant R40MC 00203 from the United States Maternal and Child Health Bureau and by a grant from the Irving B. Harris Foundation. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation took place in blocks of 4, 6 or 8 (with equal numbers to intervention and comparison group within a block
Allocation concealment (selection bias)	Low risk	Randomisation done from a series of sealed opaque envelopes, labelled with a sequential subject identification number, and containing an assignment to intervention or control group
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Not possible for the participants or study personnel to be blinded to this intervention
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Standardised validated scales used to assess outcome, but participants and assessors knew to which group participants were randomised
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Good study retention over period up to 24 months; all outcomes reported in methods reported in results; all analyses were by intention‐to‐treat
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	2 RCTs reported in the same publication. The Zelen method was used: only those participants randomised to the experimental group were told the true purpose of the trial and asked for consent. The participants in the control group were told about the study in the introduction letter for the postpartum questionnaire and they were told it was "a study on factors influencing birth".
Participants	Healthy nulliparous and parous women in labour at a hospital in Finland. 86 women were enrolled in Trial A. The actual number enrolled to each group was not noted but medical record data were collected for 79 women (41 in the support group and 38 in the control group). These 79 women represented 91.9% of the total sample
Interventions	Trial A: in 1987, the intervention was 1:1 support by midwifery students from enrolment until transfer to the postpartum ward. The midwifery students volunteered, were not specially trained in support and responsible for the other routine intrapartum care. The control group 'was cared for according to the normal routine of the midwife and by a medical student, if s(he) was on duty'. Over 70% of fathers were present
Outcomes	Labour length, medical interventions, complications (mother and baby), pharmacologic pain relief, method of birth, mothers' evaluations of their experiences
Notes	Not stated if epidural analgesia was available or if EFM was used routinely Dates of study: "spring 1987" Funding: Study supported by a grant from the Finnish Academy of Sciences. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention of how the allocation sequence was produced
Allocation concealment (selection bias)	Unclear risk	"Randomization coding was done in blocks of 6 and put into non‐transparent envelopes. The envelope was opened at the reception ward when it was decided to transfer mother to labour ward." It was not stated if the envelopes were consecutively numbered
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, participant's family, and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Outcomes were collected from medical records by a researcher who was not blinded to group assignment
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data were collected on 91.9% of the sample. A questionnaire was administered at 2‐3 days postpartum. This was completed by only 70% of the sample and thus the data were not used
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	High risk	Mothers were told the purpose of the study differentially (see methods for Trial A above)

Methods	See Hemminki 1990a.
Participants	See Hemminki 1990a. 161 women were enrolled in Trial B (81 in the support group and 80 in control).
Interventions	Trial B: in 1988, the intervention was support by a new group of midwifery students. All students were involved in the trial, not just volunteers. The students were permitted to leave their participants to witness other interventions and deliveries. The control group "was cared for according to the normal routine of the midwife" and by a medical student as enrolment was limited to days when medical students were on duty. Slightly fewer than 70% of fathers were present
Outcomes	See Hemminki 1990a
Notes	Not stated if epidural analgesia was available or if EFM was used routinely Dates of study: "autumn 1988" Funding: Study supported by a grant from the Finnish Academy of Sciences. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details provided
Allocation concealment (selection bias)	Unclear risk	The block size was reduced from the first study. "To lessen the frustration resulting from opening a code for a control mother, randomisation envelopes contained a maximum of two similar codes in sequence (not told in advance)". "Put into non‐transparent envelopes". The envelope was opened in the labour ward. It was not stated if the envelopes were consecutively numbered
Blinding of participants and personnel (performance bias)   All outcomes	High risk	No mention of blinding of participants and personnel, but blinding of participants and personnel is not possible
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	No mention of blinding of outcome assessment
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data were collected on 100% of the sample. A questionnaire was administered at 2‐3 days postpartum and completed by 93.7% of the sample
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	High risk	Mothers were told the purpose of the study differentially (see methods for Trial A above)

Methods	RCT, stratified by type of prenatal classes (Lamaze versus general)
Participants	145 nulliparous women (72 to support group and 73 to control) in the last trimester of a healthy pregnancy, booked for delivery at a Toronto, Canada, hospital
Interventions	Support provided by a monitrice (community 'lay' midwife or midwifery apprentice) compared with usual hospital care, defined as the intermittent presence of a nurse. Support described as including physical comfort measures, continuous presence, information, emotional support, and advocacy. The monitrice met with the woman twice in the latter weeks of pregnancy, to discuss her birth plans. Comparable prenatal attention was provided to the controls. All but 1 woman also had husbands or partners present during labour. Support began in early labour at home or in hospital and continued through delivery
Outcomes	Intrapartum interventions, perceived control, method of delivery
Notes	Epidural analgesia was available and EFM was used routinely Dates of study: recruitment and follow‐up complete by 1986 Funding: supported by a grant from the National Health Research and Development Program, Health and Welfare Canada. Project no. 6606‐2939‐43. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated table of random numbers
Allocation concealment (selection bias)	Low risk	Randomisation done over the phone by a third party who had no knowledge of the participant, but used the open table of random numbers
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Initial collection of medical record data were not blinded. "Duplicate abstraction was done by a second research assistant blind to the subject's study group assignment, on a random sample of 20 records. Interrater agreement of over 95% was obtained for all categories of intervention and physical outcomes." In‐home interview at 2 to 4 weeks postpartum was blinded
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Method of delivery outcome available on 88.3% of sample. Other outcomes collected on only 71% of the sample and thus not used
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	Multicentre RCT with prognostic stratification for parity and hospital
Participants	6915 nulliparous and parous women in labour at 13 hospitals in the USA and Canada (3454 to continuous labour support and 3461 to usual care). Eligibility criteria: live singleton fetus or twins, no contraindications to labour, in labour. Women were excluded if gestational age was < 34 weeks or if they were so high risk that a 1:1 patient‐nurse ratio was medically necessary
Interventions	Experimental: continuous support from staff labour and delivery nurses who had volunteered for and received a 2‐day training workshop in labour support. Prior to the trial, the support nurses had opportunities to practice their skills. They also had opportunities to continue learning from each other and the labour support trainer, throughout the trial. The nurses with training were part of the regular staffing complement of the unit and they provided care to the continuous support group but not to the usual care group. Usual care: intermittent support from a nurse who had not received labour support training
Outcomes	Intrapartum interventions, method of birth, immediate complications (mother or baby), complications (mother or baby) in the first 6‐8 weeks postpartum, perceived control, postpartum depression, breastfeeding at 6‐8 weeks, relationship with partner and with baby, likes and dislikes about birth experience and future preferences for labour support
Notes	Other support person(s) were allowed, epidural analgesia was available and EFM was used routinely Dates of study: enrolment between 19 May 1999, and 25 May 2001. Funding: supported by US PHS grant 5R01NR04684 from the National Institutes of Health, National Institute for Nursing Research. The Data Coordinating Centre in the Maternal, Infant, and Reproductive Health Research Unit is supported by grants from the Centre for Research in Women’s Health, Sunnybrook and Women’s College Health Sciences Centre, and the Department of Obstetrics and Gynaecology at the University of Toronto. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised randomisation program
Allocation concealment (selection bias)	Low risk	"Randomization was centrally controlled with the use of a computerized randomisation program at the data co‐ordinating centre, accessible by means of a touch‐tone telephone."
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, participants' families, and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Data collectors were not blinded as they read nurses' notes to collect data about type of nursing care provided. However random chart audits yielded no errors in reporting study outcomes
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data were collected on 100% of the sample. In‐hospital questionnaires were completed by 96.4% and 6 to 8 week questionnaires by 81% of the sample
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	189 nulliparous women (92 to support and 97 to control) in active labour at a community hospital serving low‐income women in South Africa
Interventions	Intervention group: support by carefully trained, volunteer lay women, for at least several hours (supporters not expected to remain after dark). Control group: intermittent care on a busy ward. Spouses/family members were not permitted
Outcomes	Intrapartum interventions, method of birth, complications (mother and baby), anxiety, pain, mothers' perceptions of labour, breastfeeding
Notes	Epidural analgesia was not available and EFM was not used routinely. While scores on an instrument measuring postpartum depression were reported in categories of "low", "moderate," and 'high", the authors stated that categorisation was not appropriate as a clinical diagnostic definition of depression. To achieve the latter, the change in score must be reported, and these data were not collected Dates of study: not clear, received by journal 1990 Funding: South African Medical Research Council. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random
Allocation concealment (selection bias)	Unclear risk	"Randomly ordered cards in sealed opaque envelopes". Not stated if consecutively numbered
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	High risk	It was not possible to keep the interviewer blind to the group assignment, as sometimes participants volunteered information which identified them as belonging to 1 group or another
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data were collected on 100% of the sample and questionnaires within 24 hours postpartum were completed by 99%. The 6‐week follow‐up interviews were completed by 78.8% of the sample, no imbalances existed between groups and thus the data were included in the analysis. At 1‐year interviews were complete for 46% of the sample and data from these were not used. Nikodem reported on a larger sample of women with 1‐year follow‐ups but the completion rate was still only 50% of the original number enrolled
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

PERMALINK

Continuous support for women during childbirth

Meghan A Bohren

G Justus Hofmeyr

Carol Sakala

Rieko K Fukuzawa

Anna Cuthbert

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings for the main comparison. Continuous support compared to usual care (all trials) for women during childbirth.

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Primary outcomes

Woman

Baby

Secondary outcomes

Woman

Baby

Longer‐term outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

(1) Random sequence generation (checking for possible selection bias)

(2) Allocation concealment (checking for possible selection bias)

(3.1) Blinding of participants and personnel (checking for possible performance bias)

(3.2) Blinding of outcome assessment (checking for possible detection bias)

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

(5) Selective reporting (checking for reporting bias)

(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)

(7) Overall risk of bias

Assessment of the quality of the evidence using the GRADE approach

Measures of treatment effect

Dichotomous data

Continuous data

Unit of analysis issues

Cluster‐randomised trials

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

(A) Three subgroup analyses that concern characteristics of the childbirth environment

(B) One subgroup analysis that concerns characteristics of the providers of labour support

(C) One subgroup analysis that concerns differences in the timing of onset of continuous support

(D) One subgroup analysis that concerns the model of support received

(E) One subgroup analysis that concerns the country income level

Sensitivity analysis

Results

Description of studies

Results of the search

1.

Included studies

Methods

Settings

Participants

Interventions and comparisons

Excluded studies

Risk of bias in included studies

Methods	RCT
Participants	This study took place in the obstetrics clinic of a state hospital in a city located in the Middle Anatolia Region in Turkey between April and August 2014. Pregnant women at least 18 years of age, who were literate, with at least a primary school education, gestational age ≥ 37 weeks, conscious, able to communicate in Turkish, and ≥ 3 cm dilated
Interventions	The intervention group (N = 36) was given routine care and continuous supportive care during labour and delivery. Supportive care was provided by 5 midwifery students from the School of Health who had taken an obstetrics course in their third year and had expressed willingness to join the study. The students were provided 24 hours of skills training directed toward continuous supportive care and practices during labour and a 2‐hour theoretical course for the research procedures that was taught by the researchers. The interventions began upon hospital admission and finished at the end of the third stage of labour. Participants in the control group (N = 36) received the routine care that was normally provided at the hospital only. At the participating hospital, pregnant women are monitored, and midwives perform the deliveries; doctors are consulted when necessary. The physical support normally offered by midwives during the first phase of labour included controlling room temperature and odours, patient positioning, and hygiene and urinary elimination
Outcomes	Delivery fear (10 item scale to measure fear during delivery) during latent, active and transitional phases of labour; pain score (assessed on a 10 cm VAS ranging from 0 (no pain) to 10 (worst pain)) during latent, active and transitional phases of labour; perceived control and support in birth (SCIB subscales include internal control, external control, and support, with a total of 33 items and a 5‐point Likert scale to score responses, scale range 33 to 165, higher score associated with higher degree of perceived support and control during birth); duration of labour (hours); use of oxytocin, and caesarean section (see note)
Notes	EFM not used routinely and epidural anaesthesia not available in the study hospital. Women who had in labour emergency caesarean section were excluded from both the intervention group (N = 3 excluded) and the control group (N = 6 excluded) of the study, as the investigators felt that the emergency situation interfered with supportive care, and control passed from the research and midwife team to the doctor. Caesarean section is included in this review as an outcome, calculated from the number of participants randomised to the intervention group (N = 36) and control group (N = 36), less the number of in labour emergency caesarean sections for each group Dates of study: April ‐ August 2014 Funding: not reported. Conflicts of interest: The authors declare no conflicts of interest.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised block assignment was used to assign 72 women to the intervention group (N = 36) and the control group (N = 36). A randomised block procedure (Vickers 2006) was performed as follows: (a) a block size of 4 was selected; (b) subjects were calculated as having 6 conditions (TTCC, TCTC, CCTT, TCCT, CTCT, and CTTC); and (c) blocks were randomly selected to determine the assignment of all 72 participants, with an allocation ratio of 1:1. Predictable block size
Allocation concealment (selection bias)	Unclear risk	No mention of central assignment, sequential numbering or opaque envelopes or containers
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Not possible for the woman/provider to be blinded due to the intervention, although the woman was blinded to differences between control and intervention. No mention of data analysis blinding
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Outcome assessor was blinded to the group assignment
Incomplete outcome data (attrition bias)   All outcomes	High risk	Data reported for 33/36 women in intervention and 30/36 women in control. All drop outs due to emergency caesarean section. Post randomisation exclusion
Selective reporting (reporting bias)	High risk	Women who underwent emergency CS were excluded from the analysis, but mode of delivery is a frequently reported outcome for labour companionship
Other bias	Low risk	No other bias identified

Methods	RCT
Participants	100 nulliparous women at term (50 to support and 50 to routine care) in active labour at a university hospital in Tehran, Iran from March to September 2003
Interventions	"Women allocated to the intervention group were shown to an isolated room and were supported by an experienced midwife. The women were free to choose their position, and able to eat and walk about freely. During labour, the midwife explained the process of labour and the importance of body relaxation. Midwife‐led support included close physical proximity, touch, and eye contact with the labouring women, and teaching, reassurance, and encouragement. The midwife remained with the woman throughout labour and delivery, and applied warm or cold packs to the woman's back, abdomen, or other parts of the body, as well as performing massage according to each woman's request." "Women allocated to the routine care group were admitted to the labour ward (where 5‐7 women labour in the same room), did not receive continuous support, and followed the routine orders of the ward. They did not have a private room, did not receive one‐to‐one care,were not permitted food, and did not receive education and explanation about the labour process. The only persons allowed in the delivery room were nurses, midwives, and doctors."
Outcomes	Duration of labour, caesarean delivery, oxytocin use, Apgar score at 5 minutes
Notes	EFM was not used routinely and epidural analgesia was not available Dates of study: March ‐ September 2003 Funding: not reported. Conflicts of interest: The authors declare that they have no conflict of interest.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	From personal communication ‐ equal numbers of envelopes were produced for each letter (see below) and put into a box. No list of treatment allocations was created
Allocation concealment (selection bias)	High risk	"Allocated to one of two groups using 4‐part, block randomisation". Used "sealed envelopes labelled A, B, C, and D: envelopes A and C (intervention group) and B and D (routine care group). Patients then chose an envelope, which was opened by the investigator". Further details from personal communication ‐ the women picked from all the envelopes produced. Once an envelope was picked it was discarded. This process was open to selection bias as women previously in the trial may have shared knowledge of which envelope contained which group with women not yet enrolled in the study
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	From personal communication "The co worker of investigator collected the outcome data and she was blind for the study group."
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record information was collected on 100% of the sample
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT of continuous support versus usual care with an 'inconspicuous observer' plus a retrospective non‐random control group. This review is restricted to comparisons of the outcomes of the participants who were randomly assigned
Participants	412 nulliparous women (212 in support group and 200 in observed group) were part of the RCT. They were aged 13 to 34 years, with singleton, term, healthy pregnancies, many not English‐speaking, in active labour at a public hospital in Texas which provides care for low‐income patients
Interventions	The description of the setting, the participants, and the type of care echo developing world conditions. All women laboured in a large 12‐bed room. For the women in the support group a doula stayed by their bedside and gave continuous support. For those in the observed group they had the routine intermittent presence of a nurse and continuous presence of an "inconspicuous observer" who "kept a record of staff contact, interaction and procedures". The observer was away from the beside and never spoke to the labouring woman
Outcomes	Analgesia/anaesthesia, labour length, artificial oxytocin use, method of birth, complications (mother and baby), neonatal health, number of women who rated their experience as negative
Notes	In instances in which outcome data (such as analgesia/anaesthesia use) in the published report were only provided for subgroups, the primary author was contacted and he provided complete outcome data for all women who were originally randomised. Family members were not allowed to be present. Epidural analgesia was available and EFM was used routinely Dates of study: not clear, accepted by journal 1991 Funding: grant HD 16915 awarded by the National Institute of Child Health and Human Development, Bethesda, Md; by the Arthur Vining Davis Foundations, Jacksonville, and by the Pittway Corporation Charitable Foundations, Chicago. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as random, however participants were randomised to the control group if they were eligible, but admitted to the hospital on days that doulas were already assigned to other patients
Allocation concealment (selection bias)	Low risk	"Randomly assigned" is stated in the report. In the protocol for the trial it states "numbered opaque envelopes" would be used. The envelopes "would contain the random assignments of the women to control or treatment groups and would be numbered sequentially"
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and labour ward staff not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Unclear who assessed the outcome data
Incomplete outcome data (attrition bias)   All outcomes	Low risk	There is some discrepancy in the number of women enrolled in the study. The report states 412 were enrolled and reports outcome data on all 412 women. But it also states that "14 women that agreed to participate were not included in the study." The reasons for not including them seem to be events that would happen after randomisation ‐ e.g. transferred due to staffing limitations, withdrew, undetected breech, interrupted observations, etc., and thus the sample appears to have numbered 426. Data are reported for 412 women (96.7% of 426)
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT. Purposefully enrolled more women to the control group. See 'Risk of bias' table below
Participants	465 healthy nulliparous women (186 to support group and 279 to control) in labour at the Social Security Hospital in Guatemala
Interventions	Support group: continuous emotional and physical support by a doula. Control group: usual hospital routines (described as no consistent support)
Outcomes	Labour length, use of artificial oxytocin, method of birth, problems during labour and birth, fetal distress, Apgar scores, transfer to neonatal intensive care nursery
Notes	No family members permitted to be present. epidural analgesia was not available and EFM was not used routinely Dates of study: not clear, accepted by journal June 1986 Funding: grants from the Thraher Fund, the Pitway Corporation Charitable Foundation, and the Maternal and Child Health Research (MC‐R‐390430). Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Enrolled using randomised design". "Pool of envelopes contained more control group to ensure similar sized groups with uncomplicated labours and deliveries." They anticipated more complications in control group based on an earlier study (Sosa 1980). No information on how allocation sequence was generated
Allocation concealment (selection bias)	Low risk	"Randomly assigned according to contents of a sealed opaque envelope. Each envelope was numbered sequentially."
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Unclear who assessed the outcomes
Incomplete outcome data (attrition bias)   All outcomes	Low risk	"Mother‐infant pairs were excluded when the mother developed a complication during labour, delivery, or post partum that required special care, if the baby's weight was below 5.5 lbs or above 8 lbs, if there were twins or congenital malformations." This occurred for about 10% of cases in both groups resulting in reported outcomes for 89.6% of those randomised. Unpublished data on the excluded women were provided by the author. Labour length data were only available for 48.4% of the sample (225 of 465) and thus not included
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	724 women (361 to support and 363 to control) admitted for delivery at a large social security hospital in Mexico City, who met the following criteria: singleton fetus, no previous vaginal delivery, < 6 cm cervical dilatation, and no indications for an elective caesarean delivery
Interventions	Support group: continuous support from 1 of 10 women who had received doula training (6 were retired nurses), throughout labour, birth, and the immediate postpartum period. Support included: emotional support, information, physical comfort measures, social communication, ensuring immediate contact between mother and baby after birth, and offering advice about breastfeeding during a single brief session postnatally. Control group: women received "routine care"
Outcomes	The main outcomes were exclusive and full breastfeeding at 1 month postpartum. Other outcomes included labour length, epidural anaesthesia, forceps birth, caesarean birth, meconium staining, and Apgar scores, as well as mothers' perceived control during childbirth, anxiety, pain, satisfaction, and self‐esteem
Notes	Partners and family members were not permitted. Epidural analgesia was available but it was not stated if EFM was used routinely Dates of study: not clear, received 9 July 1997 Funding: Wellstart International provided financial and technical support. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer generated random number list". "The treatment sequence was kept at a central level."
Allocation concealment (selection bias)	Unclear risk	"Opaque envelopes with the assignment were locked in a cabinet to which only a social worker exclusively in charge of randomisation and the principal investigator had access. An envelope with a paper inside showing to which group each woman was assigned was opened by the social worker immediately after recruitment in the labour and delivery unit". Not stated if envelopes were sequentially numbered
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Data were collected by 2 "blinded social workers" who reviewed clinical records, but records were written by staff aware of group assignment
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data and in‐hospital interview data were collected for 100% of the sample. A in‐home interview was completed at 1 month postpartum for 92.2% of the sample
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	109 Black women from Botswana (53 in support group and 56 in usual care group), mean age 19 years, 80% unmarried, mostly students, who had met the following criteria: nulliparous, in labour, pregnancy at term, no history of pregnancy complications, cephalic presentation, normal spontaneous labour with cervical dilation 1 to 6 cm, female relative present who was willing to remain with the woman for the duration of labour
Interventions	Support group: continuous presence of female relative (usually her mother) in addition to usual hospital care. Congrol group: usual hospital care, which involved staff:patient ratios of 1:4, and no companions permitted during labour
Outcomes	Spontaneous vaginal birth, vacuum extraction, caesarean birth, analgesia, amniotomy, artificial oxytocin during labour, Apgar scores (1‐ and 5‐min)
Notes	Epidural analgesia was not available and it was not stated whether EFM was used routinely Dates of study: October 1994 ‐ January 1995 Funding: part of Master's degree of Banyana Cecilia Madi, sponsored by Government of Botswana. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomly allocated." No other details provided
Allocation concealment (selection bias)	Low risk	"Selection of an opaque, numbered, sealed envelope from a box of envelopes that were shuffled in the woman's presence. When opened the envelope revealed a code indicating her group." An assistant that was not involved in the recruitment process shuffled the envelopes
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, participants' families, and labour room staff were not blinded to group allocation
Blinding of outcome assessment (detection bias)   All outcomes	High risk	The researcher, who was involved in the recruitment of participants, collected the medical record data
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data were collected on 100% of the sample
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT. Enrollment occurred at childbirth education classes and randomisation occurred when the woman arrived at hospital in labour
Participants	420 nulliparous middle and upper class women (224 on doula group and 196 in control group) were enrolled in the third trimester of an uncomplicated pregnancy in Cleveland, Ohio. All women expected to be accompanied during labour by their male partner
Interventions	Experimental group: a doula met the couple at the hospital as soon as possible after random assignment (typically within an hour of their arrival at the hospital) and remained with them throughout labour and delivery. The central component of doula support was the doula’s continuous bedside presence during labour and delivery, although her specific activities were individualised to the needs of the labouring woman. Doula support included close physical proximity, touch, and eye contact with the labouring woman, and teaching, reassurance, and encouragement of the woman and her male partner. All doulas completed training requirements that were equivalent to the DONA international doula certification. Control group: routine obstetric and nursing care which included the presence of a male partner or other support person
Outcomes	Caesarean delivery, epidural anaesthesia, oxytocin use, labour length, mode of delivery, fever during labour, satisfaction at 6 weeks postpartum
Notes	Epidural analgesia was available and EFM was used routinely. The author has been contacted for data split by study group and questionnaire data for the control group Dates of study: enrolment from October 1988 through October 1992. Funding: supported in full by Grant HD 16915 awarded by the National Institute of Child Health and Human Development, Bethesda, Maryland, USA. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details stated
Allocation concealment (selection bias)	Low risk	"When the research co‐ordinator was informed that an enrolled woman had arrived at the hospital in early active labour, she opened the next sequentially numbered opaque envelope to determine random assignment to the doula or control group". The research co‐ordinator was off‐site and called by the staff or the study participant
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, participants' family members, and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Research assistants had access to the medical records, including information about procedures and interventions. Unclear if this includes group assignment. Questionnaires were completed by the participant and her partner, before hospital discharge
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Medical record data were collected on 100% of the sample. The in‐hospital and 6‐week questionnaires were completed by 87.9% and 87.5% of the doula group. No information was provided for the control group
Selective reporting (reporting bias)	Low risk	The primary outcomes of caesarean birth and epidural anaesthesia were reported for each study group. Other labour and delivery outcomes were reported for the full sample only (not split by group). The in‐hospital and 6‐week questionnaire data were only reported for the doula group. The author has been contacted for these missing details
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	603 women from Ibadan, Nigeria with anticipated vaginal delivery were enrolled between 30 and 32 weeks' gestation at an antenatal clinic (305 to intervention and 298 to control) from November 2006 to March 2007
Interventions	Those in the experimental group were informed to bring someone of their choice to act as a companion during labour. On arrival in labour the accompanying companions were provided with an information leaflet that explained their responsibilities. These included: gentle massage of the woman’s back during contraction, reassuring words, spiritual support inform of prayers and also acting as intermediary between the woman and healthcare team. After studying the leaflets, they were allowed to seek clarifications. The information leaflet was also interpreted for those that are not literate. The attending midwife allowed and ensured companions performed their expected duties throughout. The companions were told to offer continuous support – they were to be by the patient’s side except for feeding and use of toilet until 2 hours after childbirth. Husbands were the most common support person (65.4%). The women in the control group had only routine care where relatives of patients are usually barred from the labour ward
Outcomes	Caesarean section rate, active phase of labour duration, pain score, need for analgesia, need for oxytocin augmentation, time from delivery to initiation of breastfeeding and the emotional experience during labour.
Notes	Epidural analgesia was not available and it was not stated whether EFM was used routinely. We have requested further details from the authors. The randomisation process was well done, but resulted in an imbalance in socioeconomic status between the groups. Women in the experimental group tended to be more educated (82% versus 48% with tertiary level) and skilled workers (78% versus 39%). This imbalance was noted and discussed by the authors Dates of study: November 2006 ‐ 30 March 2007 Funding: received financial support from the Gates Institute, Bloomberg School of Public Health Johns Hopkins University through the Center for Population and Reproductive Health, College of Medicine University of Ibadan, Nigeria. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The randomisation sequence was generated using a table of random numbers"
Allocation concealment (selection bias)	Low risk	"Random permuted blocks of size four were used to ensure a balanced design." "Based on the sequence of treatments generated using this method, treatment groups (A and B) were written on pieces of cardboard paper and put into sealed opaque envelopes. Each of the opaque envelopes had a serial number on it." "Two trained research assistants (RAs) non‐medical staff, supervised the randomisation procedure at every clinic. On each clinic day, consented women that met the inclusion criteria were given serial numbers with allotted treatment group based on their arrival time. Only the statistician and RAs had access to the list of numbers used to prevent clinicians’ influence on the randomisation. Each participant opened the opaque envelope in the presence of an RA, and the assigned treatment group was recorded on the woman’s medical record file."
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants, participants' families, and labour room staff were not blinded to group allocation
Blinding of outcome assessment (detection bias)   All outcomes	High risk	The treatment group was noted in the chart so it is likely that the data collectors were unblinded
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Follow‐up was completed for 97% of the sample
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	No other sources of bias noted

Methods	RCT
Participants	150 primiparous women with a single foetus, who arrived at the labour ward in active labour (4 cm cervical dilatation). The age range of the women was 18 to 34 years, and gestational age was 38 to 42 weeks. None of the women had evidence of any severe obstetric disease
Interventions	This study was carried out in maternity wards of Zahedan and Mirjaveh, Iran from July 2007 to May 2008. Women in the intervention group received doula support during active labour from an untrained woman such as a female friend or relative (mother‐in‐law, mother, sister‐in‐law, sister) who had been selected by the mother. Women in the control group (without doula support) received routine care. To avoid contamination between the intervention and control groups, separate labour rooms, screens between the beds or beds at opposite ends of the same room were used
Outcomes	Severity of pain: using a VAS at the beginning of active labour (4 cm cervical dilation) and at the end of the second active phase of labour (10 cm cervical dilatation). Duration of the active phases of labour Mode of delivery Use of medication (oxytocin/promethazine/hyosin)
Notes	Unknown if companions were typically permitted on the labour ward, if continuous EFM was used routinely, or if epidural anaesthesia was available Dates of study: July 2007 to May 2008 Funding: not clear. Conflicts of interest: not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	There is no mention of how the sequence was generated, e.g. “Subjects were selected using simple random sampling and were randomly divided into two groups: one group with doula support (n=75) and one control group (n=75)."
Allocation concealment (selection bias)	Unclear risk	There is no mention of how allocation was concealed, e.g. “Subjects were selected using simple random sampling and were randomly divided into two groups: one group with doula support (n=75) and one control group (n=75)."
Blinding of participants and personnel (performance bias)   All outcomes	High risk	There is no mention of how participants and/or personnel were blinded, but blinding of participants and personnel is not possible
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	There is no mention of blinding of outcome assessment, e.g. "The severity of pain was measured in both groups using a Visual Analogue Scale at the beginning of active labour (4 cm cervical dilation) and at the end of the second active phase of labour (10 cm cervical dilatation). Duration of the active phases of labour, the type of delivery and the use of medication (oxytocin/promethazine/hyosin) in both groups were recorded."
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	The study states that 75 women were randomised to control and 75 randomised to intervention. However, neither the results section nor table 2 (relevant outcome data), report the total number of women for each outcome assessed
Selective reporting (reporting bias)	Low risk	Outcomes reported in the method section are reported in the results section
Other bias	Low risk	No evidence of other bias

Methods	RCT, no details regarding method of random assignment
Participants	144 "healthy" women having their first baby booked for delivery at a Swedish hospital (72 to doula group and 72 to usual care). Participants were enrolled at 36 weeks' gestation
Interventions	Continuous presence by a doula who had met the woman during pregnancy, compared to usual care
Outcomes	Emergency caesarean birth and epidural analgesia
Notes	The trial author reported that the information about randomisation method and outcomes of those lost to follow‐up are no longer available. Epidural analgesia was available. It was not stated if other support person(s) were allowed or if EFM was used routinely Dates of study: March 1998 ‐ March 2000 Funding: not reported in translation. Conflicts of interest: not reported in translation.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomized' ‐ no further details provided or available
Allocation concealment (selection bias)	Unclear risk	No details provided or obtained
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and labour room staff were not blinded to group assignment
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Unclear if outcome data were collected by researches blinded to group assignment
Incomplete outcome data (attrition bias)   All outcomes	High risk	Medical record data collected on 70.1% of sample. No usable outcome data, due to serious risk of attrition bias. Outcomes are reported for 55/72 (76%) of the intervention group and 46/72 (64%) of the control group. Reason for the 41 “dropouts” were preterm birth, induction, or caesarean section “for medical reasons”, and participant withdrawal. No numbers are given for individual reasons, or by group, but it is clear that some “dropouts” were prior to labour and others were during labour. Numbers in the report show the number of dropouts was actually 43
Selective reporting (reporting bias)	Unclear risk	Sample size was based on caesarean section rate. The only outcome reported was emergency caesarean
Other bias	High risk	Trial was stopped early for "a range of largely organizational issues" when only 1/4 of the original sample size had been enrolled