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Active, not recruitingNCT05240066BIBSUpdated Jan 13, 2026

Birth Control to Improve Birth Spacing

An observational study in Contraception, Contraception Behavior and Knowledge, Attitudes, Practice, sponsored by Brigham and Women's Hospital. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,341
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • birth spacing
  • behavior
  • environmental barriers
  • pospartum
  • contraception
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In context

Contraception Behavior

132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.

This study's enrollment of 1,341 is above the median of 149 across 22 observational studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,341 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Desired birth spacing

    self-reported desire to space births

    Time frame: Baseline

  2. 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

    Time frame: Baseline

  3. 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

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. Intention to initiate contraception postpartum

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

    Time frame: Baseline

  6. Planned postpartum contraceptive method

    self-report of selected method

    Time frame: Baseline

  7. Contraceptive use

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

    Time frame: 12-week follow up

  8. 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.

    Time frame: 12-week follow up

Secondary outcomes

  1. 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.

    Time frame: 12-week follow up

Other outcomes

  1. Immediate and delayed postpartum method uptake

    contraceptive method prescribed, inserted, injected, or otherwise provided

    Time frame: 72 hours postpartum, 12 weeks postpartum

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Study locations

2 sites
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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05240066
Responsible party
Elizabeth Janiak (Assistant Professor, Brigham and Women's Hospital) — Principal investigator
First posted
Feb 15, 2022
Start date
Feb 17, 2022
Primary completion
Jan 14, 2025
Completion
Jun 30, 2026 (estimated)
Last update
Jan 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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