Birth Control to Improve Birth Spacing

Contraception Clinical Trial

— BIBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240066
• Other study ID #: 2021P000762
• Secondary ID: R21HD103977
• Status: Recruiting
• Start date: February 17, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Brigham and Women's Hospital
• Contact: Elizabeth Janiak, ScD
• Phone: 617.525.9686
• Email: ejaniak[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: June 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Contraception Behavior
• Knowledge, Attitudes, Practice

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immediate and delayed postpartum method uptake	contraceptive method prescribed, inserted, injected, or otherwise provided	72 hours postpartum, 12 weeks postpartum
Primary	Desired birth spacing	self-reported desire to space births	Baseline
Primary	Contraceptive attitudes and norms	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	Baseline
Primary	contraceptive self-efficacy	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	Baseline
Primary	Contraceptive knowledge	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.	Baseline
Primary	Intention to initiate contraception postpartum	self-reported desire to use contraception within 12 weeks of birth	Baseline
Primary	Planned postpartum contraceptive method	self-report of selected method	Baseline
Primary	Contraceptive use	Participants will be asked if they have used a contraceptive method since giving birth.	12-week follow up
Primary	Environmental barriers to contraceptive use	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.	12-week follow up
Secondary	Intimate partner violence	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.	12-week follow up