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The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka.

ABSTRACT: BACKGROUND:The International Federation of Gynaecology and Obstetrics (FIGO), in collaboration with the Sri Lankan College of Obstetrics and Gynaecologists (SLCOG), launched an initiative in 2014 to institutionalize immediate postpartum IUD (PPIUD) services as a routine part of antenatal counseling and delivery room services in Sri Lanka. In this study, we evaluate the effect of the FIGO-SLCOG PPIUD intervention in six hospitals by means of a cluster-randomized stepped-wedge trial. METHODS/DESIGN:Six hospitals were randomized into two groups of three using matched pairs. Following a 3-month baseline period, the intervention was administered to the first group, while the second group received the intervention after 9 months of baseline data collection. We collected data from 39,084 women who delivered in these hospitals between September 2015 and January 2017. We conduct an intent-to-treat (ITT) analysis to determine the impact of the intervention on PPIUD counseling and choice of PPIUD, as measured by consent to receive a PPIUD, as well as PPIUD uptake (insertion following delivery). We also investigate how factors related to counseling, such as counseling timing and quality, are linked to choice of PPIUD. RESULTS:We find that the intervention increased rates of counseling, from an average counseling rate of 12% in all hospitals prior to the intervention to an average rate of 51% in all hospitals after the rollout of the intervention (0.307; 95% CI 0.148-0.465). In contrast, we find the impact of the intervention on choice of PPIUD to be less robust and mixed, with 4.1% of women choosing PPIUD prior to the intervention compared to 9.8% of women choosing PPIUD after the rollout of the intervention (0.027; 95% CI 0.000-0.054). CONCLUSIONS:This study demonstrates that incorporating PPIUD services into postpartum care is feasible and potentially effective. Taking the evidence on both counseling and choice of PPIUD together, we find that the intervention had a generally positive impact on receipt of PPIUD counseling and, to a lesser degree, on choice of the PPIUD. Nevertheless, it is clear that the intervention's effectiveness can be improved to be able to meet the demand for postpartum family planning of women. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02718222 . Registered on 11 March 2016 (retrospectively registered).

SUBMITTER: Karra M

PROVIDER: S-EPMC6615190 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka.

Karra Mahesh M Pearson Erin E Pradhan Elina E de Silva Ranjith R Samarasekera Arnjali A Canning David D Shah Iqbal I Weerasekera Deepal D Senanayake Hemantha H

Trials 20190708 1

<h4>Background</h4>The International Federation of Gynaecology and Obstetrics (FIGO), in collaboration with the Sri Lankan College of Obstetrics and Gynaecologists (SLCOG), launched an initiative in 2014 to institutionalize immediate postpartum IUD (PPIUD) services as a routine part of antenatal counseling and delivery room services in Sri Lanka. In this study, we evaluate the effect of the FIGO-SLCOG PPIUD intervention in six hospitals by means of a cluster-randomized stepped-wedge trial.<h4>Me ...[more]

PMID: 31287021

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Project description:BACKGROUND:In Nepal, 54% of women have an unmet need for family planning within the 2 years following a birth. Provision of a long-acting and reversible contraceptive method at the time of birth in health facilities could improve access to postpartum family planning for women who want to space or limit their births. This paper examines the impact of an intervention that introduced postpartum contraceptive counseling in antenatal care and immediate postpartum intra-uterine device (PPIUD) insertion services following institutional delivery, with the intent to eventually integrate PPIUD counseling and insertion services as part of routine maternity care in Nepal. METHODS:This study took place in six large tertiary hospitals. All women who gave birth in these hospitals in the 18-month period between September 2015 and March 2017 were asked to participate. A total of 75,587 women (99.6% consent rate) gave consent to be interviewed while in postnatal ward after delivery and before discharge from hospital. We use a stepped-wedge cluster randomized design with randomization of the intervention timing at the hospital level. The baseline data collection began prior to the intervention in all hospitals and the intervention was introduced into the hospitals in two steps, with first group of three hospitals implementing the intervention 3 months after the baseline had begun, and second group of three hospitals implementing the intervention 9 months after the baseline had begun. We estimate the overall effect using a linear regression with a wild bootstrap to estimate valid standard errors given the cluster randomized design. We also estimate the effect of being counseled on PPIUD uptake. RESULTS:Our Intent-to-Treat analysis shows that being exposed to the intervention increased PPIUD counseling among women by 25 percentage points (pp) [95% CI: 14-40?pp], and PPIUD uptake by four percentage points [95% CI: 3-6?pp]. Our adherence-adjusted estimate shows that, on average, being counseled due to the intervention increased PPIUD uptake by about 17 percentage points [95% CI: 14-40?pp]. CONCLUSIONS:The intervention increased PPIUD counseling rates and PPIUD uptake among women in the six study hospitals. If counseling had covered all women in the sample, PPIUD uptake would have been higher. Our results suggest that providing high quality counseling and insertion services generates higher demand for PPIUD services and could reduce unmet need. TRIAL REGISTRATION:Trial registered on March 11, 2016 with ClinicalTrials.gov, NCT02718222 .

Project description:BackgroundThe World Health Organization recommends postpartum family planning (PPFP) for healthy birth spacing. This study is an evaluation of an intervention that sought to improve women's access to PPFP in Tanzania. The intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services for women electing PPIUD in the immediate postpartum period.MethodsThis cluster-randomized controlled trial recruited 15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016. We present the effectiveness of the intervention using a difference-in-differences approach to compare outcomes, receipt of PPIUD counseling and choice of PPIUD after delivery, between the pre- and post-intervention period in the treatment and control group. We also present an intervention adherence-adjusted analysis using an instrumental variables estimation.ResultsWe estimate linear probability models to obtain effect sizes in percentage points (pp). The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp). The adherence-adjusted estimates demonstrate that if all women had been counseled, we would have observed a 31.6 pp increase in choice of PPIUD (95% CI: 24.3 - 35.8 pp). Among women counseled, determinants of choosing PPIUD included receiving an informational leaflet during counseling and being counseled after admission for delivery services.ConclusionsThe intervention modestly increased the rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling among women delivering in study facilities. With universal PPIUD counseling, large increases in choice of PPIUD would have been observed. Giving women informational materials on PPIUD and counseling after admission for delivery are likely to increase the proportion of women choosing PPIUD.Trial registrationRegistered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.

Project description:BACKGROUND:Cluster randomised trials with unequal sized clusters often have lower precision than with clusters of equal size. To allow for this, sample sizes are inflated by a modified version of the design effect for clustering. These inflation factors are valid under the assumption that randomisation is stratified by cluster size. We investigate the impact of unequal cluster size when that constraint is relaxed, with particular focus on the stepped-wedge cluster randomised trial, where this is more difficult to achieve. METHODS:Assuming a multi-level mixed effect model with exchangeable correlation structure for a cross-sectional design, we use simulation methods to compare the precision for a trial with clusters of unequal size to a trial with clusters of equal size (relative efficiency). For a range of scenarios we illustrate the impact of various design features (the cluster-mean correlation - a function of the intracluster correlation and the cluster size, the number of clusters, number of randomisation sequences) on the average and distribution of the relative efficiency. RESULTS:Simulations confirm that the average reduction in precision, due to varying cluster sizes, is smaller in a stepped-wedge trial compared to the parallel trial. However, the variance of the distribution of the relative efficiency is large; and is larger under the stepped-wedge design compared to the parallel design. This can result in large variations in actual power, depending on the allocation of clusters to sequences. Designs with larger variations in cluster sizes, smaller number of clusters and studies with smaller cluster-mean correlations (smaller cluster sizes or smaller intra-cluster correlation) are particularly at risk. CONCLUSION:The actual realised power in a stepped-wedge trial might be substantially higher or lower than that estimated. This is particularly important when there are a small number of clusters or the variability in cluster sizes is large. Constraining the randomisation on cluster size, where feasible, might mitigate this effect.

Dataset Information

The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka.

Publications

The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka.

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