Immediate postpartum insertion of intrauterine device for contraception

Laureen M Lopez; Alissa Bernholc; David Hubacher; Gretchen Stuart; Huib AAM Van Vliet

doi:10.1002/14651858.CD003036.pub3

. 2015 Jun 26;2015(6):CD003036. doi: 10.1002/14651858.CD003036.pub3

Immediate postpartum insertion of intrauterine device for contraception

Laureen M Lopez ^1,^✉, Alissa Bernholc ², David Hubacher ³, Gretchen Stuart ⁴, Huib AAM Van Vliet ⁵

Editor: Cochrane Fertility Regulation Group

PMCID: PMC10777269 PMID: 26115018

Abstract

Background

Women who want to start intrauterine contraception (IUC) during the postpartum period might benefit from IUC insertion immediately after delivery. Postplacental insertion greatly reduces the risk of subsequent pregnancy and eliminates the need for a return visit to start contraception. Without the option of immediate insertion, many women may never return for services or may adopt less effective contraception.

Objectives

Our aim was to examine the outcomes of IUC insertion immediately after placenta delivery (within 10 minutes), especially when compared with insertion at other postpartum times. We focused on successful IUC placement (insertion), subsequent expulsion, and method use.

Search methods

We searched for trials until 1 April 2015. Sources included PubMed (MEDLINE), the Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, Web of Science, EMBASE, LILACS, ClinicalTrials.gov, and ICTRP. For the original review, the authors contacted investigators to identify other trials.

Selection criteria

We sought randomized controlled trials (RCTs) with at least one treatment arm that involved immediate IUC placement (i.e., within 10 minutes of placenta delivery). Comparison arms could have included early postpartum insertion (from 10 minutes postplacental to hospital discharge) or standard insertion (during a postpartum visit). Trials could also have compared different IUC methods or insertion techniques. Delivery may have been vaginal or cesarean. Primary outcomes were placement (insertion), subsequent expulsion, and method use at study assessment.

Data collection and analysis

For dichotomous outcomes, we used the Mantel‐Haenszel odds ratio (OR) with 95% confidence interval (CI). Earlier studies primarily reported results as life‐table rates. We aggregated trials in a meta‐analysis if they had similar interventions and outcome measures. A sensitivity analysis included studies with moderate or high quality evidence and sufficient outcome data.

Main results

We included 15 trials. Seven studies reported from 2010 to 2014 were added to eight from the original 2001 review. Newer trials compared immediate postplacental insertion versus early (10 minutes to 48 hours) or standard insertion (during the postpartum visit). Of four with full reports, three were small trials. The other three studies had conference abstracts. The eight early trials examined immediate insertion of different devices or insertion techniques. Most studies were published in the 1980s, some with limited reporting.

Our sensitivity analysis included trials with sufficient outcome data and moderate or high quality evidence. Four newer trials comparing insertion times met the inclusion criteria. Two studies used the levonorgestrel‐releasing intrauterine system (LNG‐IUS) after vaginal delivery. The other two trials placed IUC after cesarean section; one used the CuT 380A intrauterine device (IUD) and the other used the LNG‐IUS.

A pilot trial compared immediate insertion versus early or standard insertion. In groups comparing immediate versus early insertion (N = 30), all women had the LNG‐IUS inserted. By six months, the groups had the same expulsion rate and did not differ significantly in IUC use.

For immediate versus standard insertion, we conducted meta‐analyses of four trials. Insertion rates did not differ significantly between study arms. However, the trial from Uganda showed insertion was more likely for the immediate group, although the estimate was imprecise. In the meta‐analysis, expulsion by six months was more likely for the immediate group, but the confidence interval was wide (OR 4.89, 95% CI 1.47 to 16.32; participants = 210; studies = 4). IUC use at six months was more likely with immediate insertion than with standard insertion (OR 2.04, 95% CI 1.01 to 4.09; participants = 243; studies = 4). Study arms did not differ in use at 3 or 12 months in individual small trials.

Authors' conclusions

Recent trials compared different insertion times after vaginal or cesarean delivery. Evidence was limited because studies with full reports generally had small sample sizes. Overall, the quality of evidence was moderate; abstracts and older studies had limited reporting. Ongoing trials will add to the evidence, although some are small. Trials of adequate power are needed to estimate expulsion rates and side effects.

The benefit of effective contraception immediately after delivery may outweigh the disadvantage of increased risk for expulsion. Frequent prenatal visits during the third trimester provide the opportunity to discuss effective contraceptive methods and desired timing for initiation. Clinical follow‐up can help detect early expulsion, as can educating women about expulsion signs and symptoms.

Plain language summary

Intrauterine contraception soon after childbirth

Women have two main choices for intrauterine contraception (IUC): one that releases the hormone levonorgestrel, and one without hormones that contains copper. Beginning IUC use right after childbirth and before hospital discharge can be good for many reasons. The woman knows she is not pregnant, and the time and place are convenient for starting a method that works well. We looked at whether IUC would be more likely to come out on its own if put in right after birth of a baby. For women who wanted IUC but did not have it placed right away, we studied whether they returned later for insertion.

Until 1 April 2015, we ran computer searches for randomized trials of IUC inserted within 10 minutes of placenta (afterbirth) delivery. We wrote to researchers to find more studies. Trials could compare different times for insertion as well as types of IUC and ways to insert the device.

We found 15 trials. Seven recent studies compared IUC insertion right after childbirth versus early insertion (before hospital discharge) or later insertion (weeks after discharge). Four had full reports, although three were small studies. Insertion was as likely to occur when placed right after childbirth as when planned for later placement, except in a study from Uganda. For the four trials overall, the IUC came out more often on its own when placed right after childbirth than when inserted weeks later. Use at six months was more likely with insertion right after childbirth than weeks later. In single studies, the groups did not differ in use at 3 months or 12 months.

Eight older studies looked at types of IUC put in right after childbirth. Changing IUC design did not seem to affect whether IUC stayed in or whether it was used later on. Inserting IUC by hand or with a holding instrument did not seem to make a difference.

We found newer trials with full reports that compared placement times. The studies were of good quality. Ongoing trials will provide additional data, although some sample sizes are small. Larger studies would provide better information on whether the IUC came out on its own and on whether side effects occurred.

Summary of findings

for the main comparison.

Immediate insertion compared with early insertion for postpartum IUC
Patient or population: postpartum women with desire for contraceptive Setting: hospital or clinic Intervention: immediate postplacental insertion (within 10 minutes) Comparison: early insertion (10 minutes to 48 hours post delivery)
Outcomes	Relative effect  (95% CI)	Participants  (studies)	Quality of the evidence  (GRADE)
Expulsion by 6 months	OR 1.00 (95% CI 0.20 to 5.04)	30  (1 study)	⊕⊕⊕⊝ Moderate
IUC use at 6 months	OR 0.46 (95% CI 0.04 to 5.75)	30  (1 study)	⊕⊕⊕⊝  Moderate
CI: Confidence interval; OR: Odds ratio
GRADE Working Group grades of evidence  High quality: Further research is very unlikely to change our confidence in the estimate of effect.  Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.  Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.  Very low quality: We are very uncertain about the estimate.

Immediate insertion compared with standard insertion for postpartum IUC
Patient or population: postpartum women with desire for contraceptive Setting: hospital or clinic Intervention: immediate postplacental insertion (within 10 minutes) Comparison: standard insertion (at postpartum visit)
Outcomes	Relative effect  (95% CI)	Participants  (studies)	Quality of the evidence  (GRADE)
Placement per protocol	OR 4.07 (95% CI 0.54 to 30.40); I² = 68%	243 (4 studies)	⊕⊕⊕⊝  Moderate
Expulsion by 6 months	OR 4.89 (95% CI 1.47 to 16.32)	210 (4 studies)	⊕⊕⊕⊝ Moderate
IUC use at 6 months	OR 2.04 (95% CI 1.01 to 4.09)	243 (4 studies)	⊕⊕⊕⊝  Moderate
CI: Confidence interval; OR: Odds ratio
GRADE Working Group grades of evidence  High quality: Further research is very unlikely to change our confidence in the estimate of effect.  Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.  Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.  Very low quality: We are very uncertain about the estimate.

Study	Delivery type	IUC	Inadequate  randomization  and allocation concealment	No blinding	Loss to follow‐up  > 20%	Quality of evidence^a
Immediate versus early insertion (10 minutes to 48 hours)
Dahlke 2011	Vaginal	LNG‐IUS	_	‐1	_	Moderate
Ahuja 2014^b	Vaginal	CuT 380A	_	‐1	Unclear	Moderate
Singh 2014^b	Vaginal or cesarean	CuT 380A	‐1	Unclear	Unclear	Low
Immediate versus standard insertion (weeks)
Chen 2010	Vaginal	LNG‐IUS (6 to 8 weeks)	_	_	_	High
Dahlke 2011	Vaginal	LNG‐IUS (> 6 weeks)	_	‐1	_	Moderate
Whitaker 2014	Cesarean	LNG‐IUS (4 to 8 weeks)	_	_	‐1	Moderate
Lester 2015	Cesarean	CuT 380A (6 weeks)	_	‐1	_	Moderate
Ogburn 2013^b	Vaginal or cesarean	CuT 380A (4 to 12 weeks)	‐1	Unclear	Unclear	Low
Immediate insertion: IUC types, modifications, or insertion techniques
Thiery 1980	Unclear	Multiload 250 versus CuT 200	‐1	Unclear	_	Moderate
WHO 1980	Vaginal	Copper 7 versus Lippes Loop D vs Nova‐T‐PP	_	‐1	_	Moderate
Van Kets 1987	Unclear	Nova‐T‐PP vs Nova T	‐1	Unclear	_	Moderate
Lavin 1983	Unclear	Progestasert vs CuT 200	_	Unclear	‐1	Moderate
Apelo 1985	Vaginal	IPCS‐52 vs CuT 200	_	Unclear	‐1	Moderate
Cole 1984	Vaginal	Delta T vs TCu 220 Delta Loop vs Lippes Loop D Delta T (hand vs mechanical insertion) _	Unclear	‐1	Moderate
Kisnisci 1985	Unclear	Delta Loop vs Delta T	_	Unclear	_	Moderate
Xu 1996	Vaginal	CuT 380A: hand vs ring‐forceps insertion	_	_	_	High

Study	N	Placement (insertion) per protocol (%)
Study	N	Immediate	Early	Standard
Chen 2010^a	102	88	_	90
Dahlke 2011^a	46	100	100	94
Whitaker 2014^a	42	95	_	82
Lester 2015^a	68	100	_	53
Ogburn 2013	156	87	_	77
Ahuja 2014	263	_	_	_
Singh 2014	200	_	_	_

Study	N	Use at  6 months^a (%)			Expulsion by  6 months^b (%)
Study	N	Immediate	Early	Standard	Immediate	Early	Standard
Chen 2010^c	102	84	_	77	22^d	_	4
Dahlke 2011^c	46	87	93	94	27	27	0
Whitaker 2014^c	42	70	_	59	20	_	0
Lester 2015^c	68	79	_	47	3	_	6
Ogburn 2013	156	57	_	59	_	_	_
Ahuja 2014	263	89	74	_	9	24	_
Singh 2014	200	84	77	_	8	11	_

Expulsion
Study	Time frame	Immediate insertion	Early insertion	Reported P
Ahuja 2014	‐‐‐	N = 131	N = 132	‐‐‐
Ahuja 2014	6 weeks	24.1%	9.1%	.0037
Singh 2014	‐‐‐	N = 100	N = 100	‐‐‐
Singh 2014	6 months	8.3%	10.5%	.06

Study	IUC	N	Insertion  technique	Placement  (insertion)  per protocol  (reported %)	Use at  6 months^a	Expulsion by  6 months^a
Study	IUC	N	Insertion  technique	Placement  (insertion)  per protocol  (reported %)	Life‐table rates   (reported)
Thiery 1980	TCu 200	269	_	_	85.0	9.4
Thiery 1980	Multiload 250	293	_	_	88.8	7.4

WHO 1980^b	Copper 7	277	_	_	64.6	31.1
	Lippes Loop D	250	_	_	48.1	41.3
	Nova‐T‐PP	277	_	_	52.3	39.4

Van Kets 1987	Nova‐T‐PP	205	_	_	87.5	5.5
Van Kets 1987	Nova T	203	_	_	88.4	6.0

Lavin 1983	Progestasert	100	Hand	_	59.9	35.8
	Progestasert	100	Inserter	_	57.2	35.2
	TCu 200	100	Hand	_	86.3	9.0
	TCu 200	100	Inserter	_	86.1	8.1

Apelo 1985	IPCS‐52 mg	50	Hand	_	57.3	39.0
	IPCS‐52 mg	50	Inserter	_	79.6	14.2
	TCu 200	50	Hand	_	81.9	14.1
	TCu 200	50	inserter	_	89.7	10.3

Cole 1984	Delta T	728	_	99.9	81.8	11.6
	TCu 220	718	_	99.7	81.8	11.5
	Delta Loop	662	_	99.7	78.5	15.7
	Lippes Loop D	648	_	99.7	73.8	21.5
	Delta T	518	Hand	99.7	84.2	11.2
	Delta T	517	Mechanical	99.7	82.6	11.5

Kisnisci 1985	Delta Loop	122	_	99.2	96.3	3.7
Kisnisci 1985	Delta T	124	_	100.0	90.7	7.6
					Percent
Xu 1996	CuT 380A	470	Hand	_	81.3	13.0
Xu 1996	CuT 380A	440	Ring‐forceps	_	79.1	12.5

Life‐table rates per 100 women for follow‐up (6‐month)
Study	Delta Loop  Hand insertion	Delta Loop  Instrument insertion
Cole 1984	84.2%	83.0%

Life‐table rates per 100 women for follow‐up (12‐month)
Study	Insertion method	TCu 200	Progestasert
Lavin 1983	Hand	76.1	77.4
Lavin 1983	Instrument	69.7	67.7

Life‐table rates per 100 women for expulsion (12‐month) by device and insertion method
Study	TCu 200 (hand)	TCu 200 (inserter)	IPCS‐52 (hand)	IPCS‐52 (inserter)
Apelo 1985	19.9	10.3	39.0	14.2

Life‐table rates per 100 women for expulsion (12‐month)
Study	Nova‐T‐PP	Lippes Loop	Copper 7
WHO 1980	41.3	44.1	34.8

Date	Event	Description
7 May 2015	New citation required and conclusions have changed	7 new trials compared immediate insertion versus early or standard insertion; 8 earlier trials compared immediate insertion of different devices or insertion techniques
1 April 2015	New search has been performed	Search updated
26 February 2015	Amended	Moved 1 trial from Ongoing studies to Studies awaiting classification
28 January 2015	Amended	Updated terminology in Types of interventions to define 'early' and 'standard' insertion
12 January 2015	Amended	Updated wording of Objectives and Types of outcome measures to better reflect focus of this new version
4 August 2014	New search has been performed	7 new Included studies and 4 Ongoing studies

Date	Event	Description
17 February 2010	New citation required but conclusions have not changed	Preliminary results from a new trial added (Chen 2010). Also, trial in progress identified (Gilliam 2013)
16 February 2010	New search has been performed	Searches updated
15 April 2008	Amended	Converted to new review format
30 January 2001	New citation required and conclusions have changed	Substantive amendments made

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Placement (insertion)	1	30	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Expulsion by 6 months	1	30	Odds Ratio (M‐H, Fixed, 95% CI)	1.0 [0.20, 5.04]
3 Use at 3 months	1	30	Odds Ratio (M‐H, Fixed, 95% CI)	0.46 [0.04, 5.75]
4 Use at 6 months	1	30	Odds Ratio (M‐H, Fixed, 95% CI)	0.46 [0.04, 5.75]
5 Expulsion			Other data	No numeric data
6 Use at 6 months			Other data	No numeric data

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Placement (insertion) per protocol	4	243	Odds Ratio (M‐H, Random, 95% CI)	4.07 [0.54, 30.40]
2 Expulsion by 6 months	4	210	Odds Ratio (M‐H, Random, 95% CI)	4.89 [1.47, 16.32]
3 Use at 6 months	4	243	Odds Ratio (M‐H, Random, 95% CI)	2.04 [1.01, 4.09]
4 Use at 3 months	1	31	Odds Ratio (M‐H, Fixed, 95% CI)	0.43 [0.04, 5.35]
5 Use at 12 months	1	42	Odds Ratio (M‐H, Fixed, 95% CI)	2.17 [0.63, 7.44]
6 Placement (insertion)	1	156	Odds Ratio (M‐H, Fixed, 95% CI)	2.04 [0.87, 4.76]
7 Continued use at 12 months			Other data	No numeric data

Outcome or subgroup title	Statistical method	Effect size
1 Insertion per protocol	Other data	No numeric data
2 Life‐table rates per 100 women for expulsion (6‐month)	Other data	No numeric data
3 Life‐table rates per 100 women for continuation (6‐month)	Other data	No numeric data
4 Life‐table rates per 100 women for follow‐up (6‐month)	Other data	No numeric data

Life‐table rates per 100 women for expulsion (6‐month)
Study	Hand insertion	Instrument insertion
Cole 1984	11.2	11.5

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insertion per protocol	1	246	Odds Ratio (M‐H, Fixed, 95% CI)	3.07 [0.12, 76.20]
2 Life‐table rates per 100 women for expulsion (12‐month)			Other data	No numeric data
3 Life‐table rates per 100 women for pregnancy (12‐month)			Other data	No numeric data
4 Life‐table rates per 100 women for removal due to bleeding or pain (12‐month)			Other data	No numeric data
5 Life‐table rates per 100 women for continuation (12‐month)			Other data	No numeric data
6 Life‐table rates per 100 women for follow‐up (12‐month)			Other data	No numeric data

Outcome or subgroup title	Statistical method	Effect size
1 Hand insertion: Life‐table rates per 100 women for expulsion (12‐month)	Other data	No numeric data
2 Instrument insertion: Life‐table rates per 100 women for expulsion (12‐month)	Other data	No numeric data
3 Hand insertion: Life‐table rates per 100 women for continuation (12‐month)	Other data	No numeric data
4 Instrument insertion: Life‐table rates per 100 women for continuation (12‐month)	Other data	No numeric data
5 Life‐table rates per 100 women for follow‐up (12‐month)	Other data	No numeric data

Outcome or subgroup title	Statistical method	Effect size
1 Life‐table rates per 100 women for expulsion (12‐month) by device and insertion method	Other data	No numeric data
2 Life‐table rates per 100 women for removal due to bleeding or pain (12‐month) by device and insertion method	Other data	No numeric data
3 Life‐table rates per 100 women for continuation (12‐month) by device and insertion method	Other data	No numeric data
4 Life‐table rates per 100 women for expulsion (36‐month) by device and insertion method	Other data	No numeric data
5 Life‐table rates per 100 women for continuation (36‐month) by device and insertion method	Other data	No numeric data
6 Life‐table rates per 100 women for expulsion (36‐month) by device pooled	Other data	No numeric data
7 Life‐table rates per 100 women for expulsion (36‐month) by method pooled	Other data	No numeric data
8 Life‐table rates per 100 women for follow‐up (12‐month) by device and insertion method	Other data	No numeric data
9 Life‐table rates per 100 women for follow‐up (36‐month) by device and insertion method	Other data	No numeric data

Life‐table rates per 100 women for expulsion (36‐month) by device pooled
Study	TCu 200 (pooled)	IPCS‐52 (pooled)
Apelo 1985	16.4	31.3

Life‐table rates per 100 women for expulsion (36‐month) by method pooled
Study	Hand (pooled)	Inserter (pooled)
Apelo 1985	29.2	18.5

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Expulsion by 6 months	1	910	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.71, 1.54]
2 Continuation at 6 months	1	910	Odds Ratio (M‐H, Fixed, 95% CI)	1.15 [0.83, 1.59]

Methods	Location and time frame: New Delhi, India; planned time frame 16 January 2012 to mid‐2013 Design: randomized controlled trial Sample size calculation and outcome of focus: based on expulsion rate 11% in immediate group and 28% in early group, power 80% and 95% CI, attrition rate 25%; total calculated as 215 with 108 in each group
Participants	General with N: 263 women with vaginal delivery in 1 hospital Inclusion criteria: 15 to 45 years of age; willing to have postpartum CuT insertion and follow‐up until 6 months postpartum Exclusion criteria: contraindications to CuT 380A insertion; cesarean delivery
Interventions	CuT 380A IUD postplacental insertion Treatment: immediate (within 10 minutes of placenta expulsion); report refers to as "postplacental" Comparison: early (10 minutes to 48 hours post delivery); report refers to as "immediate postpartum"
Outcomes	Expulsion rate, continuation rate, complication rate, removal rate for pain and bleeding, patient acceptability, failure rate Assessment times: 6 months to 1 year
Notes	Information from oral presentation (abstract only) and clinical trial listing 5 September 2014: Investigator communicated that final report was in progress
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization
Allocation concealment (selection bias)	Low risk	Sequentially numbered, sealed opaque envelopes
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Trial listing states "not applicable"
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	Loss to follow‐up: not specified in abstract

Methods	Location and time frame: Manila, Philippines; approximately 1979 to 1982, based on related report (Cole 1984) Design: RCT comparing 4 devices and 2 insertion techniques  Sample size calculation and outcome of focus: no mention
Participants	General with N: 200 women (50 in each group) Inclusion criteria: no mention Exclusion criteria: no mention
Interventions	Immediate IUD insertion (within 10 minutes of placenta expulsion) by hand or instrument Treatment: ICPS‐52 (Intrauterine Contraceptive Progestasert System) with 52 mg reservoir of progesterone, releasing 65 μg/d over 3 years Comparison: TCu 200 IUD
Outcomes	Reported pregnancy, terminations for expulsion and bleeding or pain, and continuation Assessment times: 12‐month life‐table rates reported
Notes	ICPS‐52 was modification of Progestasert IUD that had 38 mg reservoir of progesterone, designed for 1 year of use Data on Delta Loop versus Lippes Loop D are in Cole 1984 and are not repeated for this report.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random number sequence according to correspondence with investigator and study files
Allocation concealment (selection bias)	Low risk	Sealed, sequentially numbered, opaque envelopes according to correspondence with investigator and study files
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	No mention
Incomplete outcome data (attrition bias)   All outcomes	High risk	Loss to follow‐up: not presented Follow‐up (reported 12‐month) as % women not previously terminated: ICPS‐52, 83% for hand or instrument insertion; TCu 200, 71% for hand insertion and 99% for instrument insertion

PERMALINK

Immediate postpartum insertion of intrauterine device for contraception

Laureen M Lopez

Alissa Bernholc

David Hubacher

Gretchen Stuart

Huib AAM Van Vliet

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

for the main comparison.

2.

Background

Description of the condition

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

Secondary 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

Measures of treatment effect

Dealing with missing data

Assessment of heterogeneity

Data synthesis

Sensitivity analysis

Results

Description of studies

Results of the search

1.

Included studies

1. Intervention and quality summary.

Excluded studies

Risk of bias in included studies

2.

3.

Allocation

Blinding

Incomplete outcome data

Effects of interventions

2. Immediate versus early or standard insertion: placement summary.

3. Immediate versus early or standard insertion: use and expulsion summary.

Immediate postplacental versus early insertion

1.1. Analysis.

1.2. Analysis.

1.3. Analysis.

1.4. Analysis.

1.5. Analysis.

1.6. Analysis.

Immediate postplacental versus standard insertion

2.1. Analysis.

2.2. Analysis.

2.3. Analysis.

2.4. Analysis.

2.5. Analysis.

2.6. Analysis.

2.7. Analysis.

Immediate postplacental insertion: different devices or insertion techniques

4. Comparisons of devices or insertion techniques: outcome summary.

3.1. Analysis.

5.4. Analysis.

4.1. Analysis.

Methods	Location and time frame: Pittsburgh, PA (USA), from May 2007 to October 2008 Design: randomized controlled trial Sample size calculation and outcome of focus: expected 40% of standard insertion participants would not return for insertion, 4% of inserted IUDs would be discontinued in 6 months because of removal requests, and expulsion would be 11% immediate group and 2% standard group; estimated proportions continuing IUD at 6 months were 0.850 immediate and 0.564 standard; 92 participants (46 per group) for 80% power to detect 34% difference in use at 6 months and significance level 0.05. Increased to 51 per group to allow 10% loss to follow‐up. Expected 40% would not be eligible for insertion because of post‐enrollment ineligibility criteria, increasing the total to 168.
Participants	General with N: 124 randomized; 102 remained eligible after randomization Inclusion criteria: 18 years and older; ≥ 24 0/7 weeks pregnant at enrollment; anticipates vaginal delivery; desires LNG system for postpartum contraception  Exclusion criteria: scheduled cesarean section; allergy to polyethylene or levonorgestrel or other contraindication to LNG‐IUD use; exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy without subsequent negative test of cure; leiomyomata > 3 cm diameter; uterine anomaly (other than repaired septate uterus); current cervical cancer or carcinoma in situ; desires repeat pregnancy within 1 year of delivery Post‐enrollment ineligibility: cesarean delivery; clinical diagnosis of chorioamnionitis; sexually transmitted infection without negative test of cure; rupture of membranes for > 24 hours; postpartum hemorrhage; rupture of membranes at < 34 weeks gestation; participant no longer desires IUD; precipitous delivery so investigators could not begin within 10 minutes; investigators not notified of labor and delivery
Interventions	LNG‐IUS insertion Treatment: immediate (within 10 minutes postplacental) Comparison: standard (6 to 8 weeks postpartum)
Outcomes	Insertion, IUD use, continuation of IUD, expulsion, pregnancy (tested), safety (infection and perforation), pain with insertion, quality of life, contraceptive use Assessment times: visit 6 to 8 weeks post delivery, phone interview at 3 months, and visit at 6 months
Notes	Among women randomized to immediate insertion, 5 had IUD inserted from 11 to 15 minutes postplacental.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random allocation
Allocation concealment (selection bias)	Low risk	Opaque sealed envelopes
Blinding of participants and personnel (performance bias)   All outcomes	Low risk	Study staff performing 3‐ and 6‐month evaluations were blinded to randomization assignment.
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Loss to follow‐up: 12% (5 immediate and 7 standard) Ineligible after randomized as per study criteria: 18% each group

Methods	Location and time frame: 15 sites in 13 countries from April 1979 through June 1982 Design: RCT with 3 comparisons Sample size calculation and outcome of focus: no mention
Participants	General with N: 3791 women Inclusion criteria: normal vaginal delivery and consented to immediate postpartum insertion of IUD Exclusion criteria: no mention
Interventions	IUD insertion within 10 minutes of placenta delivery Delta T (TCu 220 with 2 chromic catgut sutures tied to transverse arms; free ends were 0.5 cm in length and pointed inferiorly) versus TCu 220 Delta Loop (Lippes Loop D with 3 similar sutures tied to top of device) versus Lippes Loop D Delta Loop: hand versus mechanical insertion
Outcomes	Reported pregnancy, terminations for expulsion, and continuation Assessment time: 1, 3, and 6 months after insertion
Notes	Only RCT data are included in this review; report also summarizes data from non‐randomized studies.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random number sequence (from correspondence or study files)
Allocation concealment (selection bias)	Low risk	Sealed, sequentially numbered, opaque envelopes (from correspondence or study files)
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	No mention
Incomplete outcome data (attrition bias)   All outcomes	High risk	Loss to follow‐up: not presented Follow‐up (reported 6‐month) as % women not previously terminated: Lippes Loop D 66.1, Delta Loop 62.7, TCu 220 C 70.9, Delta T 71.0, Delta Loop hand 84.2, Delta Loop instrument 83.0

Methods	Location and time frame: Portsmouth, VA (USA), from August 2009 to January 2010 Design: RCT, pilot study  Sample size calculation: Discussion notes study was not powered to detect difference in utilization at 6 months. Pilot study was planned to determined feasibility of later trial.
Participants	General with N: 53 women in a single medical center Inclusion criteria: desired LNG‐IUS (Mirena, Bayer) for postpartum contraception at presentation for admission to labor and delivery and had no contraindication Exclusion criteria: congenital or acquired uterine anomaly including fibroids that distort uterine cavity; known or suspected uterine or cervical neoplasia or unresolved abnormal Pap smear; untreated acute cervicitis or known vaginitis including bacterial vaginosis or other lower genital tract infection; acute liver disease or liver tumor; hypersensitivity to any product component; and known or suspected carcinoma of breast Intrapartum exclusion: postpartum hemorrhage (blood loss > 500 mL); chorioamnionitis; cesarean delivery
Interventions	LNG‐IUS insertion Immediate postplacental (within 10 minutes postpartum) Early postpartum (10 minutes to 48 hours post delivery) Standard (after 6‐week postpartum visit)
Outcomes	Insertion, utilization rate, pain at time of placement, breastfeeding status, blood loss, intrauterine infection rate, expulsion rate Assessment times: 3 and 6 months post delivery by phone (n = 36) or record review (n = 7)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization
Allocation concealment (selection bias)	Low risk	Sealed, numbered opaque envelopes
Blinding of participants and personnel (performance bias)   All outcomes	High risk	No blinding according to ClinicalTrials.gov listing
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Loss to follow‐up: 2% (1 in standard group) Excluded after randomization because of cesarean section, as per trial criteria: 13% (2 each from immediate and early, 3 from standard)

Methods	Location and time frame: Ankara, Turkey, from November 1979 to August 1980 Design: RCT comparing 2 modifications of existing IUDs Sample size calculation and outcome of focus: no mention
Participants	General with N: 246 women Inclusion criteria: no mention Exclusion criteria: no mention
Interventions	Immediate IUD insertion (within 10 minutes of placenta delivery) Treatment: Delta Loop Comparison: Delta T
Outcomes	Reported pregnancy, expulsion, removal for bleeding or pain, and continuation rates Assessment times: 1, 3, 6, 12 months
Notes	1 center from Cole 1984 that reported separately
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization sequence
Allocation concealment (selection bias)	Low risk	Sealed, sequentially numbered opaque envelopes
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	No mention
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	Loss to follow‐up: not presented Follow‐up (reported 12‐month) as % women not previously terminated: Delta Loop 78.9, Delta T 86.7

Methods	Location and time frame: Santiago, Chile, from November 1978 to February 1980 Design: RCT comparing 2 standard IUDs Sample size calculation and outcome of focus: no mention
Participants	General with N: 400 women Inclusion criteria: no mention Exclusion criteria: no mention
Interventions	Immediate IUD insertion (within 10 minutes of placenta); hand or instrument insertion Treatment: Progestasert IUD contained 38 mg progesterone, releasing 65 μg/d over 1 year Comparison: TCu 200
Outcomes	Reported pregnancy, expulsion, and continuation rates Assessment times: 12‐month life‐table rates
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization sequence (from correspondence with investigator and study files)
Allocation concealment (selection bias)	Low risk	Sealed, opaque, sequentially numbered envelopes (from correspondence with investigator and study files)
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	No mention
Incomplete outcome data (attrition bias)   All outcomes	High risk	Losses to follow‐up: not presented Follow‐up (reported 12‐month life‐table rates): TCu hand, 76.1; TCu instrument, 69.7; Progestasert hand, 77.4; Progestasert instrument, 67.7

Methods	Location and time frame: Kampala, Uganda, from February 2011 to December 2011 Design: RCT; pilot study to determine feasibility of study Sample size calculation and outcome of focus: based on literature and postpartum return rates at Mulago, 40% do not return for delayed insertion and 10% discontinue in 6 months. 90% immediate group and 54% delayed group would use IUD at 6 months. Sample 30 per group for 84% power (β = 0.16) to detect difference of 36% between groups, using significance level 0.05
Participants	General with N: 68 randomized in national referral hospital Inclusion criteria: pregnant at enrollment; scheduled for cesarean delivery > 8 hours after consent; desires copper IUD; age ≥ 18; English or Luganda speaking; willing to be accompanied home from hospital and to have address recorded; willing to have home visit at 6 months postpartum if no return for scheduled visit Exclusion criteria: allergy to copper; pelvic tuberculosis; severe thrombocytopenia; positive test for gonorrhea or Chlamydia; leiomyomata or other anomaly that prevents IUD placement; cervical cancer or carcinoma in situ; desire for repeat pregnancy < 12 months; chorioamnionitis; preterm birth < 34 weeks; diagnosis of AIDS (HIV not exclusion criterion); fetal demise; hemorrhage; ruptured uterus; eclampsia; evidence of severe anemia Post‐enrollment exclusion criteria: participant no longer desires CuT 380A or for immediate insertion, interval development of any exclusion criteria; postpartum hemorrhage with active bleeding that does not allow IUD placement in 10 minutes of placenta delivery; prolonged rupture of membranes > 12 hours for standard insertion, diagnosis of active cervical infection in 3 months of planned insertion or active pelvic or cervical infection; pus at cervical os or any concern for upper genital tract infection, including fever or uterine or adnexal tenderness; diagnosis of new pregnancy; interval development of any exclusion criteria
Interventions	CuT 380A IUD inserted after cesarean section Treatment: immediate postplacental (within 10 minutes) Comparison: standard (6 weeks)
Outcomes	IUD insertion and use at 6 months post delivery, time to IUD expulsion, time to pregnancy; safety measures (infection, uterine perforation), vaginal bleeding, satisfaction Assessment times: delivery, 6‐week postpartum visit, phone at 3 months, clinic visit at 6 months
Notes	Information obtained from full report as well as ClinicalTrials.gov. Results from related abstract are also mentioned (see Averbach 2012).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Permuted‐block randomization scheme with block sizes of 4 and 6
Allocation concealment (selection bias)	Low risk	Sequentially numbered, opaque envelopes; opened after delivery of baby and placenta, given no intraoperative exclusion criteria developed
Blinding of participants and personnel (performance bias)   All outcomes	High risk	None used
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Loss to follow‐up: 10% (7/68); immediate 15% (5/34) and delayed 6% (2/34)

Methods	Location and time frame: no mention; investigator at university in Albuquerque, NM (USA) Design: randomized trial Sample size calculation and outcome of focus: no mention
Participants	General with N: 156 women Inclusion criteria: term vaginal or cesarean delivery Exclusion criteria: no mention
Interventions	Paragard IUD (CuT 380A) after vaginal or cesarean delivery Treatment: immediate (within 10 minutes of placenta delivery) Comparison: standard (4 to 12 weeks)
Outcomes	IUD insertion and continuation, reasons for discontinuation, complications Assessment times: 6‐week IUD check and contacted 3, 6, and 12 months after insertion
Notes	Information from conference abstract only 30 August 2014: Investigator communicated they are working on full report for submission in 1 to 2 months. They had not yet registered the trial at ClinicalTrials.gov.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention
Allocation concealment (selection bias)	Unclear risk	No mention
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	No mention
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	Loss to follow‐up: no mention

Methods	Location and time frame: no mention (investigator in Agra, India) Design: randomized trial Sample size calculation and outcome of focus: no mention
Participants	General with N: 200 women with term pregnancy Inclusion criteria: desires CuT 380A insertion after vaginal or cesarean delivery Exclusion criteria: severe anemia; prolonged rupture of membranes (> 18 hours); unresolved postpartum hemorrhage; extensive genital trauma; coagulopathies; distorted uterine cavity or medical disorder during pregnancy
Interventions	CuT 380A IUD insertion after vaginal or cesarean delivery Treatment: immediate postplacental (within 10 minutes) Comparison: early postpartum (10 minutes to 48 hours)
Outcomes	Efficacy, rate of expulsion, side effects, continuation, pregnancy Assessment times: 6 weeks, 3 months, 6 months postpartum
Notes	Information from conference poster and abstract; no clinical trial listing found; unable to obtain information from investigator
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention
Allocation concealment (selection bias)	Unclear risk	No mention
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	No mention
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Loss to follow‐up: 3% immediate; 5% standard

Methods	Location and time frame: Gent, Belgium, from 1976 to 1978 Design: RCT Sample size calculation and outcome of focus: no mention
Participants	General with N: 562 women requesting an IUD Inclusion criteria: no contraindication to IUD use Exclusion criteria: no mention
Interventions	"Immediately after delivery of placenta" Treatment: Multiload 250 IUD Comparison: TCu 200 IUD
Outcomes	Reported pregnancy, expulsion, removal for bleeding or pain, removal for other medical reasons, and continuation Assessment times: gross cumulative event rates shown for 6, 12, and 24 months
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"List of randomized numbers"
Allocation concealment (selection bias)	Unclear risk	No mention
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	No mention
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Loss to follow‐up (reported gross cumulative event rates): 12‐month, TCu 200 2.0 and ML Cu 250 1.6 24‐month, TCu 200 2.0 and ML Cu 250 3.1

Methods	Location and time frame: Chicago, IL (USA), from May 2007 to July 2010; Evanston, IL (USA), from April 2009 to January 2011 Design: randomized safety and efficacy study Sample size calculation and outcome of focus: assumed 60% of standard insertion would return, 20% of each group would discontinue, estimated 80% postplacental group and 48% standard group would use IUD in 12 months; 46 per group for 90% power to detect difference at alpha = 0.05; assumed 15% loss to follow‐up; planned 108 participants to have 92 participants complete trial; outcome of focus was use at 12 months
Participants	General with N: 42 women in 2 hospitals (20 postplacental and 22 standard group) Inclusion criteria: pregnant; ≥ 18 years; planning scheduled cesarean delivery; desires LNG‐IUS for contraception; speaks English  Exclusion criteria: allergy to polyethylene or levonorgestrel or other contraindication to LNG‐IUS use; positive test for gonorrhea, chlamydia, or trichomoniasis during pregnancy without treatment and subsequent test of cure confirming negative result; leiomyomata distorting uterine cavity; uterine anomaly precluding IUS placement; current cervical cancer or carcinoma in situ; desires repeat pregnancy in 12 months; history of postabortal or postpartum sepsis; randomized to postplacental IUD placement and could not undergo insertion within 10 minutes because of hemorrhage or surgical complication Exclusion at delivery: clinical evidence of infection; prolonged rupture of membranes; or no longer desiring LNG‐IUS
Interventions	LNG‐IUS after cesarean delivery Treatment: immediate postplacental insertion (within 10 minutes) Comparison: standard insertion, 4 to 8 weeks after delivery
Outcomes	Use of LNG‐IUS at 12 months after delivery; proportion with IUS inserted per protocol, expulsion, satisfaction with IUD, complications Assessment times: 3 and 6 months after delivery by telephone and 12 months after delivery in clinic (by phone for those with IUD inserted off protocol expelled without replacement or removed)
Notes	Results also in ClinicalTrial.gov posting Slow recruitment, early termination, small N (42 women)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated blocked‐randomization scheme, stratified by site
Allocation concealment (selection bias)	Low risk	Sequentially numbered, sealed opaque envelopes
Blinding of participants and personnel (performance bias)   All outcomes	Low risk	Research staff members conducting follow‐up assessments were blinded to participant allocation. ClinicalTrials.gov listing states "single blind (investigator)"
Incomplete outcome data (attrition bias)   All outcomes	High risk	Loss to follow‐up: 33% (30% immediate; 36% standard)