Dataset Information

Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.

ABSTRACT: OBJECTIVE:To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS:A 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. RESULTS:Of 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%). CONCLUSION:Intrauterine 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 SOURCE:Alydia Health, Inc. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02883673.

SUBMITTER: D'Alton ME

PROVIDER: S-EPMC7575019 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.

D'Alton Mary E ME Rood Kara M KM Smid Marcela C MC Simhan Hyagriv N HN Skupski Daniel W DW Subramaniam Akila A Gibson Kelly S KS Rosen Todd T Clark Shannon M SM Dudley Donald D Iqbal Sara N SN Paglia Michael J MJ Duzyj Christina M CM Chien Edward K EK Gibbins Karen J KJ Wine Kathryn D KD Bentum Nana Ama A NAA Kominiarek Michelle A MA Tuuli Methodius G MG Goffman Dena D

Obstetrics and gynecology 20201101 5

<h4>Objective</h4>To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.<h4>Methods</h4>A 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 ...[more]

PMID: 32909970

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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.

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.

Project description:Background. The copper intrauterine device is one of the most safe, effective, and cost-effective methods for preventing unintended pregnancy. It can be used postpartum irrespective of breastfeeding to improve birth spacing and reduce unintended pregnancy and maternal-child mortality. However, this method remains highly underutilized. Methods. We developed a multi-level intervention to increase uptake of the postpartum intrauterine device (PPIUD, defined as insertion up to six weeks post-delivery) in Kigali, Rwanda. High-volume hospitals and health centers were selected for implementation of PPIUD counseling and service delivery. Formative work informed development of a PPIUD counseling flipchart to be delivered during antenatal care, labor and delivery, infant vaccination visits, or in the community. Two-day didactic counseling, insertion/removal, and follow-up trainings were provided to labor and delivery and family planning nurses followed by a mentored practicum certification process. Counseling data were collected in government clinic logbooks. Insertions and follow-up data were collected in logbooks created for the implementation. Data were collected by trained government clinic staff and abstracted/managed by study staff. Stakeholders were involved from intervention development through dissemination of results. Results. Two hospitals (and their two associated health centers) and two additional health centers were selected. In 6-months prior to our intervention, 7.7 PPIUDs/month were inserted on average at the selected facilities. From August 2017-July 2018, we trained 83 counselors and 39 providers to provide PPIUD services. N=9,020 women received one-on-one PPIUD counseling after expressing interest in family planning who later delivered at a selected health facility. Of those, n=2,575 had PPIUDs inserted (average of 214.6 insertions/month), a 29% uptake. Most PPIUDs (62%) were inserted within 10 minutes of delivery of the placenta. Conclusions. This successful, comprehensive intervention has the potential to make a significant impact on PPIUD uptake in Rwanda. The intervention is scalable and adaptable to other sub-Saharan African countries.

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.

Project description:Background: Pain with intrauterine device (IUD) insertion is identified as a barrier to uptake of this highly effective long-acting reversible contraceptive. Several studies have assessed the efficacy of interventions to alleviate patient discomfort associated with IUD insertion, but no interventions have been clearly shown to improve procedural pain. The aim of this study was to determine whether use of a cold compress on the abdomen during IUD insertion reduces pain. Materials and Methods: This was a prospective randomized control trial of women presenting to Virginia Commonwealth University for insertion of IUD from September 2016 to October 2017. A power analysis determined that 69 subjects were needed in each arm to detect a 30% reduction in pain with a power of 80%, significance value of p < 0.05. One hundred forty-two participants were consented for the study, 69 were randomized to the control group, which received the usual management, and 73 were randomized to the study group, which received a cold compress to the abdomen before the procedure. In addition to data on the difference from pre- to postprocedure pain scales, we collected information regarding inserting provider type, gravidity/parity, body mass index, demographic information (age, race, insurance type, and level of education), history of IUD placement or cervical procedure, history of chronic pain, and the use of regular pain medications (defined as more than once per week). Statistical analysis was accomplished using t-test and chi square tests. Results: There was no difference in pre and postinsertional pain in those who received a cold compress versus the control during insertion of an IUD (3.4 vs. 3.5). The insertional pain was rated at 4.3 and 4.6 for patients who received the cold compress and the control group, respectively (p = 0.805). Conclusion: Although a cold compress is a simple, inexpensive, and safe method of pain control, this study shows no reduction in insertional pain for IUD placement.

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.

Dataset Information

Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.

Publications

Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.

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