Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT01666912
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2012-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postpartum Etonogestrel Implant for Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'C044815', 'term': 'etonogestrel'}], 'ancestors': [{'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy_bryant@med.unc.edu', 'phone': '919-843-5633', 'title': 'Amy G. Bryant, Assistant Professor', 'organization': 'UNC_ChapelHill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '6 Week Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant at normal 6 week postpartum visit\n\nContraceptive implant', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Immediate Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant prior to leaving the hospital postpartum\n\nContraceptive implant', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Continuation at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Week Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant at normal 6 week postpartum visit\n\nContraceptive implant'}, {'id': 'OG001', 'title': 'Immediate Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant prior to leaving the hospital postpartum\n\nContraceptive implant'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12-14 months', 'description': 'The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Week Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant at normal 6 week postpartum visit\n\nContraceptive implant'}, {'id': 'OG001', 'title': 'Immediate Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant prior to leaving the hospital postpartum\n\nContraceptive implant'}], 'classes': [{'categories': [{'measurements': [{'value': '8.68', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '8.29', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rapid Repeat Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Week Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant at normal 6 week postpartum visit\n\nContraceptive implant'}, {'id': 'OG001', 'title': 'Immediate Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant prior to leaving the hospital postpartum\n\nContraceptive implant'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6 Week Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant at normal 6 week postpartum visit\n\nContraceptive implant'}, {'id': 'FG001', 'title': 'Immediate Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant prior to leaving the hospital postpartum\n\nContraceptive implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '6 Week Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant at normal 6 week postpartum visit\n\nContraceptive implant'}, {'id': 'BG001', 'title': 'Immediate Postpartum Contraceptive Implant', 'description': 'randomized to receive contraceptive implant prior to leaving the hospital postpartum\n\nContraceptive implant'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '2.58', 'groupId': 'BG000'}, {'value': '21', 'spread': '2.35', 'groupId': 'BG001'}, {'value': '21', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2012-08-14', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-20', 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuation at 1 Year', 'timeFrame': '12-14 months', 'description': 'The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction', 'timeFrame': '12 months', 'description': 'To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied."'}, {'measure': 'Rapid Repeat Pregnancy', 'timeFrame': '12 months', 'description': 'To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adolescence', 'contraception', 'postpartum', 'rapid repeat pregnancy'], 'conditions': ['Adolescence', 'Contraception', 'Postpartum']}, 'descriptionModule': {'briefSummary': 'This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescents ages 14-24 attending prenatal care\n* Greater than 20 weeks estimated gestational age\n* English or Spanish-speaking\n* Desire to use the contraceptive implant for contraception postpartum\n* Anticipated delivery of a healthy infant vaginally or by cesarean.\n\nExclusion Criteria:\n\nParticipants will not be eligible for participation if they have any contraindications to contraceptive implant use, including\n\n* current or past history of thrombosis or thromboembolic disorders\n* hepatic tumors (benign or malignant)\n* active liver disease\n* undiagnosed abnormal genital bleeding\n* known or suspected carcinoma of the breast (or a personal history of breast cancer)\n* hypersensitivity to any of the components of the contraceptive implant.\n* Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate\n\nCharacteristics that would preclude involvement after delivery:\n\n* Birth of a stillborn infant.\n* Maternal ICU admission after delivery\n* Maternal postpartum hemorrhage requiring blood transfusion\n* Prolonged hospital stay (\\>7 days) postpartum\n* Coagulopathy associated with the pregnancy\n* Severe pregnancy-induced hypertension\n* Fever \\>38 degrees C postpartum\n* Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial"}, 'identificationModule': {'nctId': 'NCT01666912', 'acronym': 'PPImplant', 'briefTitle': 'Postpartum Etonogestrel Implant for Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PPI-12-0732'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '6 week postpartum contraceptive implant', 'description': 'randomized to receive contraceptive implant at normal 6 week postpartum visit', 'interventionNames': ['Drug: Contraceptive implant']}, {'type': 'EXPERIMENTAL', 'label': 'Immediate postpartum contraceptive implant', 'description': 'randomized to receive contraceptive implant prior to leaving the hospital postpartum', 'interventionNames': ['Drug: Contraceptive implant']}], 'interventions': [{'name': 'Contraceptive implant', 'type': 'DRUG', 'otherNames': ['Implanon, Nexplanon, etonogestrel contraceptive implant'], 'armGroupLabels': ['6 week postpartum contraceptive implant', 'Immediate postpartum contraceptive implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amy Bryant', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}