~111 spots leftby Apr 2026

Postpartum Vaccines and Contraception Integration for Birth Control

(PIVoT Trial)

Recruiting in Palo Alto (17 mi)
+1 other location
SA
SB
Overseen byShahina Begum, PhD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
No Placebo Group

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.

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 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.12345

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.36789

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.1011121314

Research Team

SA

Sarah Averbach, MD, MAS

Principal Investigator

University of California, San Diego

SB

Shahina Begum, PhD

Principal Investigator

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

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.

Inclusion Criteria

Postpartum women who delivered a baby within the past 12 weeks
I speak Marathi.
Reside in rural Maharashtra
See 1 more

Exclusion Criteria

Currently pregnant

Treatment Details

Interventions

  • Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT) (Cancer Vaccine)
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+
Dr. Christopher Longhurst profile image

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent profile image

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Indian Council of Medical Research

Collaborator

Trials
71
Recruited
137,000+

Dr. Rajiv Bahl

Indian Council of Medical Research

Chief Executive Officer since 2022

MD in Pediatrics from University of Delhi, PhD in Public Health from All India Institute of Medical Sciences

Dr. Sanghamitra Pati

Indian Council of Medical Research

Chief Medical Officer

MBBS and MD from MKCG Medical College, MPH from University of Maastricht, PhD from University of Maastricht

Findings from Research

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.
Contraceptive Counseling in the Postpartum Period: Could Pediatricians Have a Role?Harris, K., Sivamurthy, S., Mohiuddin, H., et al.[2021]
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.
[Postpartum contraceptive practice in hospitals of the Federal District].Morán, C., Fuentes, G., Amado, F., et al.[2006]
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.
Integrating family planning into postpartum care through modern quality improvement: experience from Afghanistan.Tawfik, Y., Rahimzai, M., Ahmadzai, M., et al.[2022]

References

Stage-based implementation of immediate postpartum long-acting reversible contraception using a reproductive justice framework. [2020]
Contraceptive Counseling in the Postpartum Period: Could Pediatricians Have a Role? [2021]
[Postpartum contraceptive practice in hospitals of the Federal District]. [2006]
Integrating family planning into postpartum care through modern quality improvement: experience from Afghanistan. [2022]
Achieving Equity in Postpartum Contraception Access. [2023]
Reproductive Health: Options, Strategies, and Empowerment of Women. [2020]
Advances in long-acting injectables, implants, and vaginal rings for contraception and HIV prevention. [2022]
Peripartum contraceptive attitudes and practices. [2007]
Postpartum and Post-Abortion Contraception: From Research to Programs. [2015]
Integrated delivery of family planning and childhood immunisation services: a mixed methods assessment of service responsiveness. [2022]
Education for contraceptive use by women after childbirth. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Counseling during Maternal and Infant Health Visits and Postpartum Contraceptive use in Uttar Pradesh, India. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Contraception for the postpartum woman. [2005]
Community sexual health providers' views on immediate postpartum provision of intrauterine contraception. [2019]