Postpartum Vaccines and Contraception Integration for Birth Control

(PIVoT Trial)

No longer recruiting at 1 trial location

Overseen By Gennifer Kully, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Currently pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of combining family planning with infant vaccinations to help new mothers in rural areas access birth control more easily. The study will test whether providing family planning advice and contraception during baby vaccination visits improves postpartum contraceptive use. Mothers who recently had a baby within the last 12 weeks, speak Marathi, live in rural Maharashtra, and haven't undergone certain medical procedures like sterilization or immediate post-birth IUD placement may qualify for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions for new mothers in rural communities.

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.

What prior data suggests that this program is safe for postpartum women?

Research has shown that combining vaccines and birth control in postpartum care can be safe and effective. Successful methods empower women, helping them make informed choices about family planning. This approach has succeeded in communities without causing major side effects.

Although specific safety data for the PIVoT program is not available, similar methods have been well-received. These programs aim to remove obstacles and make family planning easier and more accessible, especially in resource-limited areas. This suggests that the PIVoT program is likely safe, as it builds on these proven methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PIVoT approach because it integrates postpartum contraception with infant vaccination through gender-transformative family planning. Unlike the standard of care, which typically separates infant vaccination from family planning support, PIVoT combines these crucial services at a single point. This integration can potentially improve access to contraception for new mothers, making it easier and more convenient for them to manage family planning. By using this combined approach, PIVoT aims to empower women with more immediate and practical options for birth control, which could lead to better health outcomes for both mothers and their infants.

What evidence suggests that the Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming (PIVoT) is effective for postpartum contraceptive use?

This trial will compare the PIVoT approach with standard care. Studies have shown that combining family planning services with infant vaccination visits helps new mothers use birth control more effectively after giving birth. In this trial, the PIVoT approach offers family planning advice during regular baby vaccine appointments. Research indicates that this method can overcome gender-related barriers, making it easier for women to accept and use contraceptives after childbirth. Successful pilot programs have demonstrated that this integration helps more women in low-resource areas access and use birth control. By offering these services together, PIVoT aims to provide a smooth and effective way to support new mothers in planning their families. ^{1 3 6 7 8}

Who Is on the Research Team?

Sarah Averbach, MD, MAS

Principal Investigator

University of California, San Diego

Shahina Begum, PhD

Principal Investigator

Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Postpartum women who delivered a baby within the past 12 weeks

Reside in rural Maharashtra

Did not undergo sterilization, hysterectomy or immediate postpartum intrauterine device (IUD) placement

Exclusion Criteria

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive gender-transformative family planning counseling and contraception provision at the time of infant vaccination

6 weeks

Monthly visits at Village Health and Nutrition Days

Follow-up

Participants are monitored for contraceptive use and intervention feasibility, acceptability, and appropriateness

12 months

Follow-up at 6 months and 12 months postpartum

Qualitative Evaluation

In-depth interviews with participants, their husbands, and health care providers to evaluate the intervention

Post-study completion

What Are the Treatments Tested in This Trial?

Interventions

• Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)

Trial Overview 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.

How Is the Trial Designed?

Group I: PIVoT Experimental Treatment 1 Intervention

Gender-transformative family planning counseling and contraception provision at the time of infant vaccination

Group II: Standard of care Active Control 1 Intervention

Standard infant vaccination and family planning referrals

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Indian Council of Medical Research

Collaborator

Trials

71

Recruited

137,000+

Published Research Related to This Trial

A significant number of pregnant and postpartum women (over 40%) expressed a desire to change their contraceptive method after delivery, highlighting the need for tailored contraceptive counseling during this period.

Reliability, efficacy, and safety during breastfeeding were identified as key attributes for contraception, with many women feeling dissatisfied with their previous methods, especially those with unplanned pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripartum contraceptive attitudes and practices. Cwiak, C., Gellasch, T., Zieman, M.[2007]

Educational interventions for postpartum women can improve contraceptive use, particularly when initiated immediately after delivery, as seen in a study from Nepal where women who received early education were more likely to use contraception at six months (OR 1.62).

Home-based mentoring programs for adolescents showed a significant reduction in repeat pregnancies, with a study indicating fewer second births within two years compared to controls (OR 0.41), highlighting the potential effectiveness of tailored support in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education for contraceptive use by women after childbirth. Lopez, LM., Grey, TW., Hiller, JE., et al.[2020]

Postpartum women have a wide range of contraceptive options, but their choice may be influenced by whether they are breastfeeding and the natural recovery process after childbirth.

There is ongoing debate about the safety of using oral contraceptives while breastfeeding, particularly regarding how hormonal contraceptives might affect lactation and infant health, highlighting the importance of informed counseling for new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraception for the postpartum woman. Sweezy, SR.[2005]

Counseling about family planning during maternal health visits significantly boosts the likelihood of women in urban Uttar Pradesh using modern contraception after giving birth, particularly methods like female sterilization and IUDs.

Visits from community health workers (CHWs) during the extended postpartum period also greatly enhance the adoption of modern contraceptive methods, including IUDs, condoms, and hormonal contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counseling during Maternal and Infant Health Visits and Postpartum Contraceptive use in Uttar Pradesh, India. Rajan, S., Speizer, IS., Calhoun, LM., et al.[2018]

The study presents a new hospital-based model for providing long-acting reversible contraceptives immediately after childbirth, emphasizing a multidisciplinary approach and the use of implementation science to ensure effective and replicable strategies.

By applying a reproductive justice framework, the model aims to enhance reproductive health equity, with three out of five participating hospitals successfully advancing beyond the initial implementation stages, indicating its potential for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stage-based implementation of immediate postpartum long-acting reversible contraception using a reproductive justice framework. Harper, KD., Loper, AC., Louison, LM., et al.[2020]

A pilot study involving 346 postpartum women revealed that 68% of those who resumed sexual activity were not using contraception, despite only 18% wanting another child, indicating a significant gap in contraceptive use and knowledge.

Most women (86%) expressed support for pediatricians providing contraceptive counseling, suggesting a potential opportunity to improve postpartum family planning during pediatric visits, although concerns about pediatricians' qualifications and knowledge were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraceptive Counseling in the Postpartum Period: Could Pediatricians Have a Role? Harris, K., Sivamurthy, S., Mohiuddin, H., et al.[2021]

Access to a wide range of contraceptive options is essential for women's health and allows for personalized choices based on individual needs and circumstances.

The review includes important considerations for emergency contraception, postpartum contraception, and strategies for women affected by partner violence, ensuring that safety and accessibility are prioritized in contraceptive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive Health: Options, Strategies, and Empowerment of Women. Tyson, NA.[2020]

In hospitals with a formal postpartum contraceptive program, over half of postpartum and postabortion women opted for contraception or sterilization before leaving, highlighting the effectiveness of structured programs in increasing contraceptive use.

In contrast, hospitals without such programs showed a wide range of contraceptive coverage (7% to 55%), indicating that establishing formal postpartum contraception services and providing counseling are essential for improving access and informed choices for women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum contraceptive practice in hospitals of the Federal District]. Morán, C., Fuentes, G., Amado, F., et al.[2006]

Effective contraception after delivery or abortion is crucial in preventing early unintended pregnancies and their health risks, highlighting the importance of postpartum contraceptive counseling and services.

While there is limited evidence on the uptake and continuation of contraceptive methods post-abortion, positive outcomes have been observed with comprehensive abortion care and targeted counseling, suggesting potential for improved family planning services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum and Post-Abortion Contraception: From Research to Programs. Shah, IH., Santhya, KG., Cleland, J.[2015]

Multipurpose prevention technologies (MPTs) are being developed to provide women with combined protection against HIV, STIs, and unintended pregnancies, which can simplify their reproductive health management.

Recent advancements in extended-release MPTs, such as injectables, implants, and rings, aim to enhance women's autonomy and choice in sexual and reproductive health, emphasizing the need to consider user preferences in their development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in long-acting injectables, implants, and vaginal rings for contraception and HIV prevention. Krovi, SA., Johnson, LM., Luecke, E., et al.[2022]

In Malawi, family planning services integrated with childhood immunisations showed high responsiveness, particularly in areas like dignity (97.9%) and service continuity (90.9%), indicating that clients generally felt respected and that services were consistently available.

Despite some areas needing improvement, such as choice of provider (28.4%) and confidentiality (62.0%), 98.6% of clients would recommend the clinic, suggesting overall satisfaction with the integrated services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated delivery of family planning and childhood immunisation services: a mixed methods assessment of service responsiveness. Hamon, JK., Kambanje, M., Pryor, S., et al.[2022]

A survey of 156 community sexual health providers in the UK revealed that 82% were positive about implementing immediate postpartum intrauterine contraception (PPIUC), indicating strong support for this method to reduce unintended pregnancies.

Providers identified challenges such as staff time, clinical experience, and access to ultrasound for aftercare, highlighting the need for multidisciplinary support and strategies to address these barriers for successful PPIUC implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community sexual health providers' views on immediate postpartum provision of intrauterine contraception. Cooper, M., Boydell, N., Heller, R., et al.[2019]

Implementing quality improvement methods in 5 hospitals in Kabul led to a significant increase in postpartum family planning counseling, from 36% to 55%, and counseling involving husbands rose dramatically from 18% to 90%.

The proportion of postpartum women who agreed to use family planning and left the hospital with their preferred method skyrocketed from 12% to 95%, resulting in lower self-reported pregnancy rates among women who received integrated services compared to those who did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating family planning into postpartum care through modern quality improvement: experience from Afghanistan. Tawfik, Y., Rahimzai, M., Ahmadzai, M., et al.[2022]

Equitable access to contraception and education can help reduce health disparities linked to unintended pregnancies, especially during the postpartum period when individuals have better access to healthcare.

Postpartum contraceptive counseling should be carefully managed to ensure it promotes shared decision-making and avoids coercion, taking into account the specific needs and preferences of individuals regarding different contraceptive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Equity in Postpartum Contraception Access. McAllister, A., Christensen, T., Dixit, E., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05732142

Postpartum Integration of Vaccines and Contraception Trial This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant vaccination ...

2. reporter.nih.gov reporter.nih.gov/search/7S3Jh1Ya5USG9yxGiQ_jiA/project-details/10840827

RePORT RePORTER - National Institutes of Health (NIH) | The objective of this study is to pilot test PIVoT (Postpartum Integration of Vaccines and contraception through gender-Transformative programming), delivered ...

3. withpower.com withpower.com/trial/phase-contraception-6-2023-26641

Postpartum Vaccines and Contraception Integration for ... This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant vaccination ...

4. highergov.com highergov.com/grant/R21HD108351/

Grant R21HD108351 San Diego University Of California The objective of this study is to pilot test PIVOT (Postpartum Integration of Vaccines and Contraception through Gender-Transformative Programming), delivered ...

5. gh.bmj.com gh.bmj.com/content/bmjgh/10/2/e016638.full.pdf

Successful strategies that address gender-related barriers ... They achieved this through quality improvement strat- egies that seamlessly integrated contraception services into the continuum of postpartum and postabortion.

6. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05732142

Postpartum Integration of Vaccines and Contraception Trial ... This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant ...

7. medrxiv.org medrxiv.org/content/10.1101/2024.06.21.24309318v2.full.pdf

Successful strategies that address gender-related barriers ... The gender-transformative strategies reported in the studies shared a commitment to empowering women with the autonomy to make informed ...

8. fphighimpactpractices.org fphighimpactpractices.org/briefs/family-planning-and-immunization-integration/

Family Planning and Immunization Integration This HIP Brief focuses on integration of family planning with immunization during the extended postpartum period, which is the one-year period after delivery.