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Birth Control to Improve Birth Spacing (BIBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05240066
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
Boston Medical Center
Harvard Medical School (HMS and HSDM)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Elizabeth Janiak, Brigham and Women's Hospital

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
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.

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Study Type : Observational
Estimated 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 : February 17, 2022
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control




Primary Outcome Measures :
  1. Desired birth spacing [ Time Frame: Baseline ]
    self-reported desire to space or births

  2. 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


  3. 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


  4. 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.

  5. Intention to initiate contraception postpartum [ Time Frame: Baseline ]
    self-reported desire to use contraception within 12 weeks of birth

  6. Planned postpartum contraceptive method [ Time Frame: Baseline ]
    self-report of selected method

  7. Contraceptive use [ Time Frame: 12-week follow up ]
    Participants will be asked if they have used a contraceptive method since giving birth.

  8. 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.


Secondary Outcome Measures :
  1. Intimate partner violence [ Time Frame: 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:
  1. Immediate and delayed postpartum method uptake [ Time Frame: 72 hours postpartum, 12 weeks postpartum ]
    contraceptive method prescribed, inserted, injected, or otherwise provided



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05240066


Contacts
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Contact: Elizabeth Janiak, ScD 617.525.9686 ejaniak@bwh.harvard.edu
Contact: Sarah Johns, MPH 617-525-8191 sjohns@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Janiak, ScD    617-525-9686    ejaniak@bwh.harvard.edu   
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Katharine White, MD    617-414-3745    katharine.white@bmc.org   
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)
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Responsible Party: Elizabeth Janiak, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT05240066    
Other Study ID Numbers: 2021P000762
R21HD103977 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Janiak, Brigham and Women's Hospital:
birth spacing
behavior
environmental barriers
pospartum
contraception