Hans 2013.
| 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 |
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| 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 |
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| 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. |
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| 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 |