Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 12:04 AM
Study NCT ID:
NCT01443533
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2011-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Birth Control Use After Childbirth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2011-09-27', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported use of LARC method', 'timeFrame': 'After six-week postpartum visit'}], 'secondaryOutcomes': [{'measure': 'Self-reported interest in use of a LARC method', 'timeFrame': 'After six-week postpartum visit'}, {'measure': 'Self-reported use of any contraceptive method', 'timeFrame': 'After six-week postpartum visit'}, {'measure': 'Self-reported reasons for not using the contraceptive method of choice', 'timeFrame': 'After six-week postpartum visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Contraception behavior', 'Postnatal care', 'Health education', 'Randomized controlled trial'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '20541171', 'type': 'BACKGROUND', 'citation': 'Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.'}, {'pmid': '20591202', 'type': 'BACKGROUND', 'citation': 'Lopez LM, Hiller JE, Grimes DA. Postpartum education for contraception: a systematic review. Obstet Gynecol Surv. 2010 May;65(5):325-31. doi: 10.1097/OGX.0b013e3181e57127.'}, {'pmid': '17138775', 'type': 'BACKGROUND', 'citation': "Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0."}, {'pmid': '16622143', 'type': 'BACKGROUND', 'citation': 'Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC. Birth spacing and risk of adverse perinatal outcomes: a meta-analysis. JAMA. 2006 Apr 19;295(15):1809-23. doi: 10.1001/jama.295.15.1809.'}, {'pmid': '26212318', 'type': 'DERIVED', 'citation': 'Zerden ML, Tang JH, Stuart GS, Norton DR, Verbiest SB, Brody S. Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period. Womens Health Issues. 2015 Nov-Dec;25(6):616-21. doi: 10.1016/j.whi.2015.06.004. Epub 2015 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial that will evaluate the impact of a brief educational script on the method of birth control that women receive at their 6-week postpartum visit. The one-minute script ("LARC script") is given to women in the hospital during their postpartum admission. It informs patients about long-acting reversible contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine device. The investigators hypothesize that women who are randomized to receive the LARC script will be more likely to report that they are using a LARC method, when queried immediately after their six-week postpartum visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who are admitted to the postpartum unit at WakeMed Hospital\n* Delivery of a live infant \\>24 weeks gestational age\n* Age 14-45 years\n* Ability to speak either English or Spanish fluently\n* Willing to be contacted by phone until at least 8 weeks after delivery\n\nExclusion Criteria:\n\n* History of a tubal ligation or hysterectomy\n* Partner has already had a vasectomy\n* History of fertility treatment to conceive this pregnancy\n* Previous randomization into the study'}, 'identificationModule': {'nctId': 'NCT01443533', 'briefTitle': 'Study of Birth Control Use After Childbirth', 'organization': {'class': 'OTHER', 'fullName': 'WakeMed Health and Hospitals'}, 'officialTitle': 'A Randomized Controlled Trial of a Brief Educational Script on Postpartum Contraceptive Uptake', 'orgStudyIdInfo': {'id': 'WakeMed 864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LARC script', 'description': 'Received routine postpartum counseling and LARC script.', 'interventionNames': ['Behavioral: LARC Script']}, {'type': 'NO_INTERVENTION', 'label': 'No LARC script', 'description': 'Received only routine postpartum counseling'}], 'interventions': [{'name': 'LARC Script', 'type': 'BEHAVIORAL', 'description': 'The LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods.', 'armGroupLabels': ['LARC script']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'WakeMed Hospital', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WakeMed Health and Hospitals', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jennifer H. Tang', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}