Birth Control to Improve Birth Spacing

Active, not recruiting

• Conditions: Contraception; Knowledge, Attitudes, Practice; Birth Spacing; Contraception Behavior

• Registration Number: NCT05240066
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This study aims to investigate the drivers of postpartum contraceptive use with a prospective cohort. The study will clarify the role of contraceptive knowledge, attitudes, norms, and self-efficacy in driving intention to initiate contraception postpartum and describe the impact of environmental barriers on enacting intended postpartum contraception initiation.

Detailed Description

This study will be a sequential mixed-methods design with a prospective cohort to identify and explore barriers to contraceptive initiation both immediately after birth and prior to hospital discharge, as well as throughout the fourth trimester. It will include a baseline patient survey, electronic medical record data pull, follow up survey, and qualitative interviews.

The investigators will enroll 1400 patients into the prospective cohort, selecting individuals enrolled at prenatal care visits at two sites. The baseline survey will be self-administered. The investigators will then contact participants for a follow-up survey at 12 weeks postpartum. Surveys will be self-administered through a link received by text message or email. Additional analyses will draw on retrospectively collected medical record data.

The investigators will invite a subset of 25-30 study subjects to participate in qualitative interviews.

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-15
• Study Start: 2022-02-17
• Status Verified: 2024-08
• Primary Completion: 2025-01-14
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1341

Inclusion Criteria

• Age 18 or older
• Pregnant
• Attending prenatal care visits at one of the two study sites

Exclusion Criteria

• Under the age of 18
• Cannot complete a survey in English or Spanish
• Do not have physical or cognitive ability to complete a survey on a tablet

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contraceptive knowledge	Baseline	measured via the Contraceptive Knowledge Assessment (Haynes et al 2017), 0-25 score range, higher scores reflect greater knowledge. Haynes MC, Ryan N, Saleh M, Winkel AF, Ades V. Contraceptive Knowledge Assessment: validity and reliability of a novel contraceptive research tool. Contraception. 2017 Feb;95(2):190-197. doi: 10.1016/j.contraception.2016.09.002. Epub 2016 Sep 9.
Contraceptive attitudes and norms	Baseline	measured via validated psychometric scales; Examining Contraceptive Use and Unmet Need Study, 12-58 range, higher score indicates more knowledge, citation: Callegari, Lisa S., MD, MPH, Zhao, Xinhua, PhD, Schwarz, Eleanor Bimla, MD, MS, Rosenfeld, Elian, PhD, Mor, Maria K., PhD, \& Borrero, Sonya, MD, MS. (2017). Racial/ethnic differences in contraceptive preferences, beliefs, and self-efficacy among women veterans. American Journal of Obstetrics and Gynecology, 216(5), 504.e1-504.e10.; DOI: 10.1016/j.ajog.2016.12.178
Planned postpartum contraceptive method	Baseline	self-report of selected method
Desired birth spacing	Baseline	self-reported desire to space births
Intention to initiate contraception postpartum	Baseline	self-reported desire to use contraception within 12 weeks of birth
Environmental barriers to contraceptive use	12-week follow up	Participants will rate the difficulty in accessing their desired contraceptive method after giving birth and respond to the reasons why it is - or is not - easy to access.
contraceptive self-efficacy	Baseline	measured via validated psychometric scales; Examining Contraceptive Use and Unmet Need Study, 12-58 range, higher score indicates more knowledge, citation: Callegari, Lisa S., MD, MPH, Zhao, Xinhua, PhD, Schwarz, Eleanor Bimla, MD, MS, Rosenfeld, Elian, PhD, Mor, Maria K., PhD, \& Borrero, Sonya, MD, MS. (2017). Racial/ethnic differences in contraceptive preferences, beliefs, and self-efficacy among women veterans. American Journal of Obstetrics and Gynecology, 216(5), 504.e1-504.e10.; DOI: 10.1016/j.ajog.2016.12.178
Contraceptive use	12-week follow up	Participants will be asked if they have used a contraceptive method since giving birth.

Secondary Outcome Measures

Name	Time	Method
Intimate partner violence	12-week follow up	measured via validated psychometric scales; Abuse Assessment Screen, 5 items, citation: Soeken, K. L., McFarlane, J., Parker, B., \& Lominack, M. C. (1998). The Abuse Assessment Screen: A clinical instrument to measure frequency, severity, and perpetrator of abuse against women. In J. C. Campbell (Ed.), Sage series on violence against women. Empowering survivors of abuse: Health care for battered women and their children (pp. 195-203). Thousand Oaks, CA, US: Sage Publications, Inc.

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States