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Active, Not Recruiting

NCT Number: NCT05240066

Birth Control to Improve Birth Spacing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Contraception Behavior Birth Spacing Contraception Behavior Knowledge, Attitudes, Practice Reproductive Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Desired birth spacing

    Time frame: Baseline

    self-reported desire to space births

  2. Contraceptive attitudes and norms

    Time frame: 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

  3. contraceptive self-efficacy

    Time frame: 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

  4. Contraceptive knowledge

    Time frame: 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.

  5. Intention to initiate contraception postpartum

    Time frame: Baseline

    self-reported desire to use contraception within 12 weeks of birth

  6. Planned postpartum contraceptive method

    Time frame: Baseline

    self-report of selected method

  7. Contraceptive use

    Time frame: 12-week follow up

    Participants will be asked if they have used a contraceptive method since giving birth.

  8. Environmental barriers to contraceptive use

    Time frame: 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.

Secondary outcomes

  1. Intimate partner violence

    Time frame: 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.

Other outcomes

  1. Immediate and delayed postpartum method uptake

    Time frame: 72 hours postpartum, 12 weeks postpartum

    contraceptive method prescribed, inserted, injected, or otherwise provided

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Harvard Medical School (HMS and HSDM)

Registry information

Official study title

Birth Control to Improve Birth Spacing: a Prospective Longitudinal Cohort Study

Acronym: BIBS

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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