Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-28 @ 9:23 AM
Study NCT ID:
NCT05240066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Birth Control to Improve Birth Spacing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1341}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immediate and delayed postpartum method uptake', 'timeFrame': '72 hours postpartum, 12 weeks postpartum', 'description': 'contraceptive method prescribed, inserted, injected, or otherwise provided'}], 'primaryOutcomes': [{'measure': 'Desired birth spacing', 'timeFrame': 'Baseline', 'description': 'self-reported desire to space births'}, {'measure': 'Contraceptive attitudes and norms', 'timeFrame': 'Baseline', 'description': '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.\n\nDOI: 10.1016/j.ajog.2016.12.178'}, {'measure': 'contraceptive self-efficacy', 'timeFrame': 'Baseline', 'description': '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.\n\nDOI: 10.1016/j.ajog.2016.12.178'}, {'measure': 'Contraceptive knowledge', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Intention to initiate contraception postpartum', 'timeFrame': 'Baseline', 'description': 'self-reported desire to use contraception within 12 weeks of birth'}, {'measure': 'Planned postpartum contraceptive method', 'timeFrame': 'Baseline', 'description': 'self-report of selected method'}, {'measure': 'Contraceptive use', 'timeFrame': '12-week follow up', 'description': 'Participants will be asked if they have used a contraceptive method since giving birth.'}, {'measure': 'Environmental barriers to contraceptive use', 'timeFrame': '12-week follow up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Intimate partner violence', 'timeFrame': '12-week follow up', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['birth spacing', 'behavior', 'environmental barriers', 'pospartum', 'contraception'], 'conditions': ['Contraception', 'Contraception Behavior', 'Knowledge, Attitudes, Practice', 'Birth Spacing']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe investigators will invite a subset of 25-30 study subjects to participate in qualitative interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nAdditionally, 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.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Pregnant\n* Attending prenatal care visits at one of the two study sites\n\nExclusion Criteria:\n\n* Under the age of 18\n* Cannot complete a survey in English or Spanish\n* Do not have physical or cognitive ability to complete a survey on a tablet'}, 'identificationModule': {'nctId': 'NCT05240066', 'acronym': 'BIBS', 'briefTitle': 'Birth Control to Improve Birth Spacing', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Birth Control to Improve Birth Spacing: a Prospective Longitudinal Cohort Study', 'orgStudyIdInfo': {'id': '2021P000762'}, 'secondaryIdInfos': [{'id': 'R21HD103977', 'link': 'https://reporter.nih.gov/quickSearch/R21HD103977', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Medical Center', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elizabeth Janiak', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}