Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-03-14 @ 8:41 AM
Study NCT ID:
NCT02144259
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2014-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Impact of Contraception on Postpartum Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}, {'id': 'C044815', 'term': 'etonogestrel'}], 'ancestors': [{'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'courtney.schreiber@uphs.upenn.edu', 'phone': '215-615-5234', 'title': 'Dr. Courtney Schreiber', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "First, we chose to exclude nursing women. Second, we had a small sample with power to detect one standard deviation difference in weight loss. Third, all data were collected prospectively,thus we did not have each participant's pre-pregnancy weight."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DMPA Group', 'description': 'Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.\n\nDMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Implanon Group', 'description': 'Subjects randomized to receive Implanon immediately post-partum.\n\nImplanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Subjects selecting their own method of contraception or no contraception.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DMPA Group', 'description': 'Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.\n\nDMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.'}, {'id': 'OG001', 'title': 'Implanon Group', 'description': 'Subjects randomized to receive Implanon immediately post-partum.\n\nImplanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Subjects selecting their own method of contraception or no contraception.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '10.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months from postpartum (baseline)', 'description': 'Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups', 'unitOfMeasure': 'percent weight lost', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DMPA Group', 'description': 'Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.\n\nDMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.'}, {'id': 'OG001', 'title': 'Implanon Group', 'description': 'Subjects randomized to receive Implanon immediately post-partum.\n\nImplanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Subjects selecting their own method of contraception or no contraception.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.', 'unitOfMeasure': 'number of pregnancies', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Contraceptive Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DMPA Group', 'description': 'Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.\n\nDMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.'}, {'id': 'OG001', 'title': 'Implanon Group', 'description': 'Subjects randomized to receive Implanon immediately post-partum.\n\nImplanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Subjects selecting their own method of contraception or no contraception.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Satisfaction will be measured in response to the question, "How satisfied are you with your current birth control method?" This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from "Very Good" to "Very Poor". "Good" or "Very Good" responses will be analyzed as having been satisfied with the method.', 'unitOfMeasure': 'percentage of women satisfied w. method', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DMPA Group', 'description': 'Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.\n\nDMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.'}, {'id': 'FG001', 'title': 'Implanon Group', 'description': 'Subjects randomized to receive Implanon immediately post-partum.\n\nImplanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Subjects selecting their own method of contraception or no contraception.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DMPA Group', 'description': 'Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.\n\nDMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.'}, {'id': 'BG001', 'title': 'Implanon Group', 'description': 'Subjects randomized to receive Implanon immediately post-partum.\n\nImplanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Subjects selecting their own method of contraception or no contraception.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.06', 'spread': '4.68', 'groupId': 'BG000'}, {'value': '22.42', 'spread': '3.81', 'groupId': 'BG001'}, {'value': '26.59', 'spread': '5.42', 'groupId': 'BG002'}, {'value': '24.02', 'spread': '4.63', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-23', 'studyFirstSubmitDate': '2014-05-19', 'resultsFirstSubmitDate': '2014-12-19', 'studyFirstSubmitQcDate': '2014-05-20', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-23', 'studyFirstPostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Contraceptive Satisfaction', 'timeFrame': '1 year', 'description': 'Satisfaction will be measured in response to the question, "How satisfied are you with your current birth control method?" This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from "Very Good" to "Very Poor". "Good" or "Very Good" responses will be analyzed as having been satisfied with the method.'}], 'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '6 months from postpartum (baseline)', 'description': 'Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups'}], 'secondaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': '1 year', 'description': 'The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Weight']}, 'descriptionModule': {'briefSummary': 'This is a prospective mixed methods study to assess weight changes in women randomized to receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who choose non-hormonal contraception or no contraception immediately postpartum. After enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series of questions, take a pregnancy test, and be weighed. Total length of participation for each subject is 1 year or until pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* Aged 18-45 at enrollment (inclusive)\n* Immediately postpartum of a live singleton infant, 37 weeks gestation, at HUP\n* Desiring to delay another pregnancy for 6 months\n* Willing and able to follow the study protocol\n\nExclusion Criteria:\n\n* Breastfeeding during study participation\n* Plans for relocation outside of Philadelphia in the next six months\n* Plans for use of weight loss medication or diet pills in the next six months\n* Women who wish to start Implanon ® or DMPA prior to discharge but who do not want to be randomized. 5. Issues or concerns in the judgment of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study'}, 'identificationModule': {'nctId': 'NCT02144259', 'acronym': 'PPWL', 'briefTitle': 'The Impact of Contraception on Postpartum Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'The Impact of Contraception on Postpartum Weight Loss: a Prospective Study', 'orgStudyIdInfo': {'id': '813000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DMPA group', 'description': 'Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.', 'interventionNames': ['Drug: DMPA immediately postpartum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Implanon group', 'description': 'Subjects randomized to receive Implanon immediately post-partum.', 'interventionNames': ['Drug: Implanon immediately postpartum']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Subjects selecting their own method of contraception or no contraception.'}], 'interventions': [{'name': 'DMPA immediately postpartum', 'type': 'DRUG', 'otherNames': ['DepoProvera, depot medroxyprogesterone acetate (DMPA)'], 'description': 'DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.', 'armGroupLabels': ['DMPA group']}, {'name': 'Implanon immediately postpartum', 'type': 'DRUG', 'otherNames': ['etonogestrel implant'], 'description': 'Implanon ® is a subdermal implant that contains 68mg of etonogestrel.', 'armGroupLabels': ['Implanon group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Courtney A Schreiber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}