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Clinical Trials/NCT05240066
NCT05240066
Active, not recruiting
Not Applicable

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

Brigham and Women's Hospital2 sites in 1 country1,341 target enrollmentFebruary 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contraception
Sponsor
Brigham and Women's Hospital
Enrollment
1341
Locations
2
Primary Endpoint
Desired birth spacing
Status
Active, not recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2022
End Date
June 30, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Janiak

Assistant Professor

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • 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

Outcomes

Primary Outcomes

Desired birth spacing

Time Frame: Baseline

self-reported desire to space births

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.

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

Planned postpartum contraceptive method

Time Frame: Baseline

self-report of selected method

Intention to initiate contraception postpartum

Time Frame: Baseline

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

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.

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

Contraceptive use

Time Frame: 12-week follow up

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

Secondary Outcomes

  • Intimate partner violence(12-week follow up)

Study Sites (2)

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