Trial Summary
What is the purpose of this trial?This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant vaccination services, and to evaluate preliminary effectiveness of this approach on postpartum contraceptive use in a low resource, rural setting.
What safety data exists for postpartum vaccines and contraception integration?The provided research does not directly address safety data for the specific treatment of postpartum vaccines and contraception integration. However, it highlights the importance of contraception in the postpartum period, the need for tailored contraceptive methods, and the significance of counseling. It also discusses the development of multipurpose prevention technologies and the importance of considering user preferences, which may indirectly relate to safety considerations. More specific studies or data would be needed to directly address the safety of the treatment in question.136912
Is the treatment in the trial 'Postpartum Vaccines and Contraception Integration for Birth Control' a promising treatment?Yes, integrating family planning with postpartum care, like vaccines and health visits, is promising because it helps women access contraception more easily after childbirth. This approach can reduce unplanned pregnancies and improve maternal and infant health by providing timely and repeated opportunities for women to learn about and use contraception.257813
What data supports the idea that Postpartum Vaccines and Contraception Integration for Birth Control is an effective treatment?The available research shows that integrating family planning into postpartum care can significantly increase the use of contraception among new mothers. For example, in Afghanistan, after implementing a program to integrate family planning into postpartum care, the proportion of women who received family planning counseling before leaving the hospital increased from 36% to 55%. Additionally, the number of women who left the hospital with their preferred contraceptive method rose from 12% to 95%. This suggests that providing contraception and counseling during the postpartum period is effective in helping women plan their families and reduce the likelihood of unintended pregnancies.14101114
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for postpartum women who speak Marathi, delivered a baby within the last 8 weeks, live in rural Maharashtra, and have not had sterilization or certain immediate post-birth contraceptive procedures. Pregnant women cannot participate.Treatment Details
The study tests a program that combines family planning with infant vaccination services to see if it increases birth control use after childbirth in rural areas. It's focused on changing gender norms to improve health outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: PIVoTExperimental Treatment1 Intervention
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
Group II: Standard of careActive Control1 Intervention
Standard infant vaccination and family planning referrals
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Research locations nearbySelect from list below to view details:
University of California, San DiegoLa Jolla, CA
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
Indian Council of Medical ResearchCollaborator
References
[Postpartum contraceptive practice in hospitals of the Federal District]. [2006]For many women living in developing areas, childbirth is the only time when they receive medical care in a clinical setting. These women may not return until they are ready to deliver their next baby. Without access to family planning counseling and effective contraceptive methods, they are likely to become pregnant again within a year or two. Where contraceptive information and services are available to women receiving maternity care, many choose to begin using contraception in the postpartum period. Some elect to have an IUD inserted immediately after delivery or to undergo sterilization while still in the hospital. Under a postpartum contraceptive program administered by the IMSS in one hospital and the same program established in another hospital of the SSA, more than half of postpartum and postabortion women began using contraception or underwent sterilization before they left the hospital. In contrast, the other hospitals under the analysis showed a wide range of contraception coverage from 7 to 55 percent. A formal postpartum contraception program is necessary to establish in all the hospitals in order to improve coverage. Counseling is an important component for all women who must have adequate information before they choose a contraceptive method.
Contraception for the postpartum woman. [2005]The postpartum woman has the full array of contraception options available to her to prevent a subsequent pregnancy. Two factors may influence the choice of the method and the timing of the onset of use (when pregnancy risk increases): the infant feeding mode chosen and the reproductive involution process. The major controversial area regarding contraception postpartum is the use of oral contraceptives if the mother is breastfeeding (ie, if and how do steroids affect the lactation process or infant health). This article reviews the physiologic and hormonal changes that occur after birth, examines the data available in relation to the influence of steroidal contraceptives on lactation, and presents postpartum implications of the use of the spectrum of contraceptive choices. The nurse can provide an important role in counseling postpartum women regarding contraceptive alternatives and supporting families in attaining their childbearing goals.
Peripartum contraceptive attitudes and practices. [2007]During pregnancy and the postpartum period, women may be more receptive to different methods of contraception for postpartum use. Few studies have focused on the peripartum population. In this study, currently pregnant and postpartum women were surveyed about their attitudes toward contraception, particularly in relation to the index pregnancy. Important contraceptive attributes for women included reliability, efficacy, and safety during breast-feeding, especially in the postpartum period. Over 80% of women surveyed were using contraception prior to pregnancy, but nearly 20% were not satisfied with the method used. Dissatisfaction with their method was more likely among women whose pregnancy was unplanned (36% vs. 9%). Over 40% of peripartum women indicated a desire to change their contraceptive after delivery. Sixty-five percent of women had received only limited information about intrauterine contraception before the survey. The results indicate that childbirth has a profound effect on contraceptive priorities and desires, especially toward long-term methods.
Integrating family planning into postpartum care through modern quality improvement: experience from Afghanistan. [2022]To address low contraceptive use in Afghanistan, we supported 2 large public maternity hospitals and 3 private hospitals in Kabul to use modern quality improvement (QI) methods to integrate family planning into postpartum care. In 2012, QI teams comprising hospital staff applied root cause analysis to identify barriers to integrated postpartum family planning (PPFP) services and to develop solutions for how to integrate services. Changes made to service provision to address identified barriers included creating a private counseling space near the postpartum ward, providing PPFP counseling training and job aids to staff, and involving husbands and mothers-in-law in counseling in person or via mobile phones. After 10 months, the proportion of postpartum women who received family planning counseling before discharge in the 5 hospitals increased from 36% to 55%, and the proportion of women who received family planning counseling with their husbands rose from 18% to 90%. In addition, the proportion of postpartum women who agreed to use family planning and left the hospital with their preferred method increased from 12% to 95%. Follow-up telephone surveys with a random sample of women who had received PPFP services in the 2 public hospitals and a control group of postpartum women who had received routine hospital services found significant differences in the proportion of women with self-reported pregnancies: 3% vs. 15%, respectively, 6 months after discharge; 6% vs. 22% at 12 months; and 14% vs. 35% at 18 months (P
Education for contraceptive use by women after childbirth. [2020]Contraceptive education is generally a standard component of postpartum care, although the effectiveness is seldom examined. The assumptions that form the basis of such programs include postpartum women being motivated to use contraception and that they will not return to a health provider for family planning advice. Women may wish to discuss contraception both prenatally and after hospital discharge. Nonetheless, two-thirds of postpartum women have unmet needs for contraception. In the USA, many adolescents have repeat pregnancies within a year of giving birth.
Postpartum and Post-Abortion Contraception: From Research to Programs. [2015]Contraception following delivery or an induced abortion reduces the risk of an early unintended pregnancy and its associated adverse health consequences. Unmet need for contraception during the postpartum period and contraceptive counseling and services following abortion have been the focus of efforts for the last several decades. This article provides an introduction to the more focused contributions that follow in this special issue. We discuss the validity and measurement of the concept of unmet need for family planning during the postpartum period. We then present key findings on postpartum contraceptive protection, use dynamics, and method mix, followed by an assessment of interventions to improve postpartum family planning. The evidence on postabortion contraceptive uptake and continuation of use remains thin, although encouraging results are noted for implementation of comprehensive abortion care and for the impact of post-abortion contraceptive counseling and services. Drawing on these studies, we outline policy and program implications for improving postpartum and post-abortion contraceptive use.
Counseling during Maternal and Infant Health Visits and Postpartum Contraceptive use in Uttar Pradesh, India. [2018]Postpartum family planning is a compelling concern of global significance due to its salience to unplanned pregnancies, and to maternal and infant health in developing countries. Yet, women face the highest level of unmet need for contraception in the year following a birth. A cost-effective way to inform women about their risk of becoming pregnant after the birth of a child is to integrate family planning counseling and services with maternal and infant health services.
Community sexual health providers' views on immediate postpartum provision of intrauterine contraception. [2019]Increasing access to effective postpartum contraceptive methods can reduce the risk of unintended pregnancy and short inter-birth intervals. The need for an additional postpartum visit can be a barrier to women accessing intrauterine contraception after childbirth. Immediate postpartum intrauterine contraception (PPIUC) provision is known to be safe, but is not routinely available in the UK. Establishing this service requires multidisciplinary support, including from community and maternity stakeholders. The aim of this study was to determine the views of community sexual health providers towards PPIUC implementation.
Reproductive Health: Options, Strategies, and Empowerment of Women. [2020]Contraception is paramount to the overall health and longevity of women. Most women in the United States use birth control in their reproductive lifetimes. All options should be available and easily accessible to permit individualization and optimization of chosen methods. Current contraceptive methods available in the United States are reviewed. Emergency contraception, contraception in the postpartum period, and strategies to tailor methods to those affected by partner violence are also addressed. Tables and flow charts help providers and patients compare various contraceptive methods, optimize the start of a method, and identify resources for addressing safety in those with underlying medical conditions.
Stage-based implementation of immediate postpartum long-acting reversible contraception using a reproductive justice framework. [2020]The immediate postpartum period is a favorable, safe, and effective time to provide long-acting reversible contraceptives, yet it is not available widely. We describe an innovative hospital-based approach to immediate postpartum long-acting reversible contraceptives that includes (1) an emphasis on multidisciplinary teambuilding and identification of champions, (2) a focus on the use of implementation science at every stage of the process to develop a systematic and replicable strategy, and (3) an imperative to apply a reproductive justice framework to immediate postpartum long-acting reversible contraceptive implementation. Our model was developed with the use of implementation science best practices. Implementation teams comprised of diverse stakeholders were formed and included champions to promote progress. Our team assessed the implementation context for immediate postpartum long-acting reversible contraceptives and used the findings to develop a readiness assessment for hospitals. A stage-based implementation checklist was then developed to outline necessary infrastructure to support an immediate postpartum long-acting reversible contraceptive initiative. A reproductive justice lens guided planning and implementation. The 3 innovative aspects of our implementation process resulted in a systematic, multidisciplinary, and culturally appropriate model for immediate postpartum long-acting reversible contraceptives that can be replicated across hospitals. Implementation teams and champions moved the work forward at each hospital, and 3 of the 5 participating hospitals moved beyond the exploration stage of implementation during the engagement. Patient education materials and provider training incorporated person-centered and reproductive justice frameworks. Our hope is to continue to partner with stakeholders to better understand how our efforts to support hospital provision of immediate postpartum long-acting reversible contraceptives can increase reproductive health equity rather than perpetuate disparity.
Contraceptive Counseling in the Postpartum Period: Could Pediatricians Have a Role? [2021]Unplanned pregnancies lead to adverse health outcomes and contribute to economic burdens. A lack of continuity and consistency in immediate postpartum care may be a contributor. The most frequent postpartum medical encounters occur with the child's pediatric health care provider, which represents an opportunity to discuss postpartum contraception. Therefore, our objective was to evaluate postpartum family planning knowledge and behavior in women, and to assess the potential acceptability of a pediatrician-delivered intervention to improve knowledge of and convenient access to contraception among postpartum women.
Advances in long-acting injectables, implants, and vaginal rings for contraception and HIV prevention. [2022]Worldwide, women face compounding reproductive health risks, including human immunodeficiency virus (HIV), sexually-transmitted infections (STIs), and unintended pregnancy. Multipurpose prevention technologies (MPTs) offer combined protection against these overlapping risks in singular prevention products that offer potential for simplified use, lower burden, higher acceptability, and increased public health benefits. Over the past decade, substantial progress has been made in development of extended-release MPTs, which have further potential to grant sexual and reproductive health autonomy to women globally and to offer choice for women to accommodate varying needs during their reproductive lives. Here, we highlight the advances made in injectable, implant, and ring delivery forms, and the importance of incorporating end-user preferences early in the research and development of these products.
Integrated delivery of family planning and childhood immunisation services: a mixed methods assessment of service responsiveness. [2022]Postpartum women represent a considerable share of the global unmet need for modern contraceptives. Evidence suggests that the integration of family planning (FP) with childhood immunisation services could help reduce this unmet need by providing repeat opportunities for timely contact with FP services. However, little is known about the clients' experiences of FP services that are integrated with childhood immunisations, despite being crucial to contraceptive uptake and repeat service utilisation.
Achieving Equity in Postpartum Contraception Access. [2023]Equitable access to contraception and contraceptive education has the potential to mitigate health disparities related to unintended pregnancy. Pregnancy and the postpartum window frequently offer reduced insurance barriers to healthcare, increased interaction with healthcare systems and family planning providers, and an opportune time for many individuals to receive contraception; however, there are additional considerations in method type for postpartum individuals, and contraceptive counseling must be thoughtfully conducted to avoid coercion and promote shared decision-making. This commentary reviews method-specific considerations and suggests priorities for achieving equity in postpartum contraceptive access.