Evaluation of a multi-level intervention to improve postpartum intrauterine device services in Rwanda.
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ABSTRACT:
SUBMITTER: Ingabire R
PROVIDER: S-EPMC6266741 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionPostpartum family planning is an effective means of achieving improved health outcomes for women and children, especially in low- and middle-income settings. We assessed the cost-effectiveness of an immediate postpartum intrauterine device (PPIUD) initiative compared with standard practice in Bangladesh and Tanzania (which is no immediate postpartum family planning counseling or service provision) to inform resource allocation decisions for governments and donors.MethodsA decision analysis was constructed to compare the PPIUD program with standard practice. The analysis was based on the number of PPIUD insertions, which were then modeled using the Impact 2 tool to produce estimates of cost per couple-years of protection (CYP) and cost per disability-adjusted life years (DALYs) averted. A micro-costing approach was used to estimate the costs of conducting the program, and downstream cost savings were generated by the Impact 2 tool. Results are presented first for the program as evaluated, and second, based on a hypothetical national scale-up scenario. One-way sensitivity analyses were conducted.ResultsCompared to standard practice, the PPIUD program resulted in an incremental cost-effectiveness ratio (ICER) of US$14.60 per CYP and US$91.13 per DALY averted in Bangladesh, and US$54.57 per CYP and US$67.67 per DALY averted in Tanzania. When incorporating estimated direct health care costs saved, the results for Bangladesh were dominant (PPIUD is cheaper and more effective versus standard practice). For Tanzania, the PPIUD initiative was highly cost-effective, with the ICER (incorporating direct health care costs saved) estimated at US$15.20 per CYP and US$18.90 per DALY averted compared to standard practice. For the national scale-up model, the results were dominant in both countries.Conclusions/implications: The PPIUD initiative was highly cost-effective in Bangladesh and Tanzania, and national scale-up of PPIUD could produce long-term savings in direct health care costs in both countries. These analyses provide a compelling case for national governments and international donors to invest in PPIUD as part of their family planning strategies.
| S-EPMC8087427 | biostudies-literature
Project description:ImportanceIntrauterine device (IUD) expulsion increases the risk of unintended pregnancy; how timing of postpartum IUD insertion and breastfeeding are associated with risk of expulsion is relevant to the benefit-risk profile.ObjectiveTo evaluate the association of postpartum timing of IUD insertion and breastfeeding status with incidence and risk of IUD expulsion.Design, setting, and participantsThe Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study included women aged 50 years or younger with an IUD insertion between 2001 and 2018. The breastfeeding analysis focused on a subcohort of women at 52 or fewer weeks post partum with known breastfeeding status. The study was conducted using data from electronic health records (EHRs) at 4 research sites with access to EHR: 3 Kaiser Permanente sites (Northern California, Southern California, Washington) and the Regenstrief Institute (Indiana). Data analysis was conducted from June to November 2019.ExposuresTiming of IUD insertion post partum was categorized into discrete time periods: 0 to 3 days, 4 days to 6 or fewer weeks, more than 6 weeks to 14 or fewer weeks, more than 14 weeks to 52 or fewer weeks, and non-post partum (>52 weeks or no evidence of delivery). Breastfeeding status at the time of insertion was determined from clinical records, diagnostic codes, or questionnaires from well-baby visits.Main outcomes and measuresIncidence rates and adjusted hazard ratios (aHRs) were estimated using propensity scores to adjust for confounding.ResultsThe full cohort included 326 658 women (mean [SD] age, 32.0 [8.3] years; 38 911 [11.9%] Asian or Pacific Islander; 696 [0.2%] Hispanic Black; 56 180 [17.2%] Hispanic other; 42 501 [13.0%] Hispanic White; 28 323 [8.7%] non-Hispanic Black; 137 102 [42.0%] non-Hispanic White), and the subcohort included 94 817 women. Most IUDs were levonorgestrel-releasing (259 234 [79.4%]). There were 8943 expulsions. The 5-year cumulative incidence of IUD expulsion was highest for insertions 0 to 3 days post partum (10.73%; 95% CI, 9.12%-12.61%) and lowest for insertions more than 6 weeks to 14 or fewer weeks post partum (3.18%; 95% CI, 2.95%-3.42%). Adjusted HRs using women with non-post partum IUD insertion as the referent were 5.34 (95% CI, 4.47-6.39) for those with postpartum insertion at 0 to 3 days; 1.22 (95% CI, 1.05-1.41) for those with postpartum insertion at 4 days to 6 or fewer weeks; 1.06 (95% CI, 0.95-1.18) for those with postpartum insertion at more than 6 to 14 or fewer weeks; and 1.43 (95% CI, 1.29-1.60) for those with postpartum insertion at more than 14 to 52 or fewer weeks. In the subcohort, 5-year cumulative incidence was 3.49% (95% CI, 3.25%-3.73%) for breastfeeding women and 4.57% (95% CI, 4.22%-4.95%) for nonbreastfeeding women; the adjusted HR for breastfeeding vs not breastfeeding was 0.71 (95% CI, 0.64-0.78).Conclusions and relevanceIn this study of real-world data, IUD expulsion was rare but more common with immediate postpartum insertion. Breastfeeding was associated with lower expulsion risk.
| S-EPMC8886522 | biostudies-literature
Project description:BACKGROUND:The 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. METHODS:This 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. RESULTS:We 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. CONCLUSIONS:The 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 REGISTRATION:Registered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.
| S-EPMC7218519 | biostudies-literature
Project description:During the year following the birth of a child, 40% of women are estimated to have an unmet need for contraception. The copper IUD provides safe, effective, convenient, and long-term contraceptive protection that does not interfere with breastfeeding during the postpartum period. Postpartum IUD (PPIUD) insertion should be performed by a trained provider in the early postpartum period to reduce expulsion rates and complications, but these services are not widely available. The International Federation of Obstetricians and Gynecologists (FIGO) will implement an intervention that aims to institutionalize PPIUD training as a regular part of the OB/GYN training program and to integrate it as part of the standard practice at the time of delivery in intervention hospitals.This trial uses a cluster-randomized stepped wedge design to assess the causal effect of the FIGO intervention on the uptake and continued use of PPIUD and of the effect on subsequent pregnancy and birth. This trial also seeks to measure institutionalization of PPIUD services in study hospitals and diffusion of these services to other providers and health facilities. This study will also include a nested mixed-methods performance evaluation to describe intervention implementation.This study will provide critical evidence on the causal effects of hospital-based PPIUD provision on contraceptive choices and reproductive health outcomes, as well as on the feasibility, acceptability and longer run institutional impacts in three low- and middle-income countries.Trial registered on March 11, 2016 with ClinicalTrials.gov, NCT02718222 .
| S-EPMC5117577 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.MethodsA multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device.ResultsOf 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%).ConclusionIntrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality.Funding sourceAlydia Health, Inc.Clinical trial registrationClinicalTrials.gov, NCT02883673.
| S-EPMC7575019 | biostudies-literature
Project description:BackgroundIntrauterine contraceptive device (IUCD) prevents unwanted pregnancy. An immediate postpartum period is a good opportunity to place IUCD for women who want to delay pregnancy. However, in Sub-Saharan Africa mainly in Ethiopia, this procedure is not widely used. This study aimed to determine the utilization and factors associated with an immediate postpartum intrauterine contraceptive device (IPPIUCD).MethodsMulti-level facility-based cross-sectional study was conducted from Januarey12 to March 12/2019GC on 423 women who delivered at selected hospitals of the west Gojjam zone. A systematic random sampling technique was applied to select study participants. Proportional allocations of samples were done based on the delivery caseload of each hospital. Data were entered in Epi info version 7.1 software and exported to SPSS version 23 for editing, cleaning, and analysis. Bivariable and multivariable logistic regression analysis were performed to determine factors associated with the utilization of IPPIUCD.ResultThe utilization of IPPIUCD was 4.02 % (95% CI: 1.65, 5.24). The following factors were significantly associated with IPPIUCD utilization; Being age 35-49 (AOR: 2.98; 1.31, 4.68), College and above education (5.01; 2.21, 7.90), Being counseled about IPPIUD (2.76: 1.79, 7.58), and needing of birth spacing >36 months (2.01: 1.52, 10.12).ConclusionThe utilization of IPPIUCD was low in selected hospitals of west Gojjam zone. According to this finding; age between 35-49 years, having college and above education, being counseled about IPPIUCD, and needing above 36 months birth spacing were significant factors for utilization of IPPIUCD. Encouraging women's education and informing health professionals of the importance of IPPIUCD may enhance IPPIUCD utilization. This finding may be useful in both reproductive health promotion at an individual level and policy-making regarding this issue.
| S-EPMC7820927 | biostudies-literature
Project description:BackgroundImmediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast-feeding outcomes.ObjectiveThis study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast-feeding outcomes.Study designWe conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast-feed, spoke English or Spanish, were aged 18-40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4-12 weeks' postpartum. Prespecified exclusion criteria included delivery <37.0 weeks' gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast-feeding. We conducted per-protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent-to-treat analysis. We powered the study for the primary outcome, breast-feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention.ResultsWe met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast-feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70-86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76-91%). The 5% difference in breast-feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, -5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, -4.8 to 8.2 hours), noninferior by log-rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group.ConclusionOur results of noninferior breast-feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device insertion suggest that immediate postpartum intrauterine device insertion is an acceptable option for women planning to breast-feed and use the levonorgestrel intrauterine device. Expulsion rates are higher with immediate postpartum levonorgestrel intrauterine device insertion compared to delayed insertion, but this disadvantage may be outweighed by the advantages of immediate initiation of contraception. Providers should offer immediate postpartum intrauterine device insertion to breast-feeding women planning to use the levonorgestrel intrauterine device.
| S-EPMC6040814 | biostudies-literature
Project description:OBJECTIVE:To determine the association between provider training level and postplacental intrauterine device (IUD) outcomes following insertion instruction by email only. STUDY DESIGN:We conducted a single-center chart review of demographics, insertion and clinical outcomes within 6 months of delivery for 116 patients who underwent postplacental levonorgestrel 52?mg IUD placement from October 1, 2016, to March 31, 2017. RESULTS:We confirmed IUD retention, removal or expulsion in 87 of 116 (75.0%) patients by 6 months after delivery. Complete expulsion or removal for malposition occurred in 20 (23.0%) patients and more frequently after vaginal than cesarean delivery (30.2% vs. 4.2%, OR 9.93 [95% CI 1.25-78.96]) and when a postgraduate year (PGY) 1 physician placed the IUD compared to a PGY 2-4 or attending physician (37.5% vs. 14.5%, OR 3.52 [95% CI 1.25-9.94]). CONCLUSION:Postplacental levonorgestrel 52?mg IUD expulsion rates are associated with provider training level as well as delivery route, though the individual association of each of these factors is difficult to ascertain given the high degree of collinearity between these two variables in our study.
| S-EPMC6351181 | biostudies-literature
Project description:BACKGROUND:The recent scale-up of prevention of mother-to-child transmission of HIV (PMTCT) services has rapidly accelerated antiretroviral therapy (ART) uptake among pregnant and postpartum women in sub-Saharan Africa. The Mother and Infant Retention for Health (MIR4Health) study evaluates the impact of a combination intervention administered by trained lay health workers to decrease attrition among HIV-positive women initiating PMTCT services and their infants through 6 months postpartum. METHODS:This was a qualitative study nested within the MIR4Health trial. MIR4Health was conducted at 10 health facilities in Nyanza, Kenya from September 2013 to September 2015. The trial intervention addressed behavioral, social, and structural barriers to PMTCT retention and included: appointment reminders via text and phone calls, follow-up and tracking for missed clinic visits, PMTCT health education at home visits and during clinic visits, and retention and adherence support and counseling. All interventions were administered by lay health workers. We describe results of a nested small qualitative inquiry which conducted two focus groups to assess the experiences and perceptions of lay health workers administering the interventions. Discussions were recorded and simultaneously transcribed and translated into English. Data were analyzed using framework analysis approach. RESULTS:Study findings show lay health workers played a critical role supporting mothers in PMTCT services across a range of behavioral, social, and structural domains, including improved communication and contact, health education, peer support, and patient advocacy and assistance. Findings also identified barriers to the uptake and implementation of the interventions, such as concerns about privacy and stigma, and the limitations of the healthcare system including healthcare worker attitudes. Overall, study findings indicate that lay health workers found the interventions to be feasible, acceptable, and well received by clients. CONCLUSIONS:Lay health workers played a fundamental role in supporting mothers engaged in PMTCT services and provided valuable feedback on the implementation of PMTCT interventions. Future interventions must include strategies to ensure client privacy, decrease stigma within communities, and address the practical limitations of health systems. This study adds important insight to the growing body of research on lay health worker experiences in HIV and PMTCT care. TRIAL REGISTRATION:Clinicaltrials.gov NCT01962220 .
| S-EPMC5763814 | biostudies-literature
Project description:OBJECTIVE:To evaluate outcomes of a national postpartum (within 48?h of delivery) copper intrauterine device placement (PPCuIUD) program in six "high-focus states" with high unmet family planning need in India. STUDY DESIGN:We identified high-volume district hospitals that provided PPCuIUD in six (Bihar, Jharkhand, Uttar Pradesh, Uttarakhand, Madhya Pradesh and Chhattisgarh) Indian states (two per state). Each selected hospital maintained a list of PPCuIUD acceptors with contact phone numbers. We randomly selected 100 women at each site for inclusion in a telephone survey of IUD outcomes at 1 year. Questions regarded IUD expulsion, discontinuation because of symptoms (e.g., pain, bleeding, discharge), discontinuation for other reasons and use of alternative contraception if discontinuation reported. RESULTS:We could contact 844 of the 1200 randomly selected women, of whom 673 (79.7%) had postplacental insertion (within 10?min of delivery), while 171 (20.3%) had an early postpartum insertion (between 10?min to 48?h after delivery). Of those contacted, 530 women (62.8%) reported continuing with the method beyond 1 year, 63 (7.5%) reported having an expulsion, 163 (19.3%) reported having removals for associated side effects (bleeding, pain and discharge), and 88 (10.4%) reported having removals for other reasons. After removal or expulsion, almost half of the women (46.5%) did not switch to any other modern contraceptive method. CONCLUSION:PPCuIUD continuation rate at 1?year was 62.8%. Most removals within 1 year were due to associated side effects. Almost half of the women discontinuing PPCuIUD did not switch to an alternative modern contraceptive method. IMPLICATIONS:The 1-year continuation rate of PPCuIUD achieved through a large-scale national program in India is satisfactory. The program though needs to address the low uptake of other modern contraceptive methods after discontinuation.
| S-EPMC6467543 | biostudies-literature