Birth Control to Improve Birth Spacing

NCT05240066 | Active Not Recruiting

• 2 other identifiers: 2021P000762R21HD103977
• Study Type: observational
• Target: 1,341
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

birth spacing; behavior; environmental barriers; pospartum; contraception

Outcome Measures

Primary Outcomes (8)

• Desired birth spacing

  self-reported desire to space births

  Baseline

• 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

• 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

• 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

• Intention to initiate contraception postpartum

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

  Baseline

• Planned postpartum contraceptive method

  self-report of selected method

  Baseline

• Contraceptive use

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

  12-week follow up

• 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 Outcomes (1)

• Intimate partner violence

  12-week follow up

Other Outcomes (1)

• Immediate and delayed postpartum method uptake

  72 hours postpartum, 12 weeks postpartum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will enroll 1,400 patients into the prospective cohort, selecting individuals enrolled at prenatal care visits at Boston Medical Center and Brigham and Women's Hospital main campus. All subjects enrolled in the baseline survey who deliver at enrollment sites will be included in electronic medical records and contacted for a follow-up survey at 12 weeks postpartum. Additionally, the investigators will invite a subset of the study subjects (25-30 patients) who report significant barriers to contraceptive uptake in the 12-week postpartum follow up survey to participate in qualitative interviews.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Contraception Behavior; Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 15, 2022
• Study Start: February 17, 2022
• Primary Completion: January 14, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)