BIBS: Birth Control to Improve Birth Spacing

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05240066

Collaborator

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

1,400

Enrollment

Locations

16.4

Anticipated Duration (Months)

700

Patients Per Site

42.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception Contraception Behavior Knowledge, Attitudes, Practice Birth Spacing

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 Design

Study Type:

Observational

Anticipated Enrollment :

1400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 17, 2022

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Outcome Measures

Primary Outcome Measures

Desired birth spacing [Baseline]
self-reported desire to space or births
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
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 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.
Intention to initiate contraception postpartum [Baseline]
self-reported desire to use contraception within 12 weeks of birth
Planned postpartum contraceptive method [Baseline]
self-report of selected method
Contraceptive use [12-week follow up]
Participants will be asked if they have used a contraceptive method since giving 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.

Secondary Outcome Measures

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.

Other Outcome Measures

Immediate and delayed postpartum method uptake [72 hours postpartum, 12 weeks postpartum]
contraceptive method prescribed, inserted, injected, or otherwise provided

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

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