Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-28 @ 3:30 PM
Study NCT ID:
NCT01463202
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2011-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C050795', 'term': 'N,N-dimethyl-4-anisidine'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}], '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': 'fpr@upmc.edu', 'phone': '412-641-5496', 'title': 'Principal Investigator', 'organization': 'Center for Family Planning Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'DMPA Postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum\n\nDepot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DMPA at 4-6 Weeks After Delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery\n\nDepot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMPA Postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum\n\nDepot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)'}, {'id': 'OG001', 'title': 'DMPA at 4-6 Weeks After Delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery\n\nDepot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)'}], 'classes': [{'title': '2 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '4 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '6 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '8 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '12 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '16 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '20 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '24 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '28 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Any breastfeeding', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Formula only', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum', 'description': 'Any breastfeeding at specific time intervals postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 ppt withdrawn postrandomization due to enrollment violation (did not meet eligibility criteria)'}, {'type': 'SECONDARY', 'title': 'Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMPA Postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum\n\nDepot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)'}, {'id': 'OG001', 'title': 'DMPA at 4-6 Weeks After Delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery\n\nDepot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)'}], 'classes': [{'categories': [{'title': 'DMPA, IUD, implant, or sterilization', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Less effective than DMPA', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Lost to followup', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Use of DMPA, IUD, implant, or sterilization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMPA Postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum\n\nDepot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)'}, {'id': 'OG001', 'title': 'DMPA at 4-6 Weeks After Delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery\n\nDepot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks postpartum', 'description': 'Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes 14 participants with a missed call at 8 weeks postpartum'}, {'type': 'SECONDARY', 'title': 'Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMPA Postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum\n\nDepot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)'}, {'id': 'OG001', 'title': 'DMPA at 4-6 Weeks After Delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery\n\nDepot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)'}], 'classes': [{'title': '2 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '4 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '6 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '8 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '12 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '16 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '20 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '24 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '28 weeks postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Exclusive breastfeeding', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Any formula', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': 'Missed call', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum', 'description': 'Exclusive breastfeeding at specific time intervals postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants withdrew during follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DMPA Postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum\n\nDepot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)'}, {'id': 'FG001', 'title': 'DMPA at 4-6 Weeks After Delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery\n\nDepot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '27 ineligible postpartum (26 no longer eligible, 1 withdrew consent)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Since participants could be recruited antepartum but may have changed their mind about breastfeeding or DMPA use post-partum, eligibility criteria were re-assessed postpartum, prior to randomization, thus the number of women enrolled in the study (184) does not equal the number of women randomized (157).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DMPA Postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum\n\nDepot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)'}, {'id': 'BG001', 'title': 'DMPA at 4-6 Weeks After Delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery\n\nDepot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '24.4', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '24.1', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-16', 'size': 213652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-14T14:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2011-10-27', 'resultsFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2011-10-31', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-14', 'studyFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA', 'timeFrame': '2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum', 'description': 'Any breastfeeding at specific time intervals postpartum'}], 'secondaryOutcomes': [{'measure': 'Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA', 'timeFrame': '6 months', 'description': 'Use of DMPA, IUD, implant, or sterilization'}, {'measure': 'Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA', 'timeFrame': '8 weeks postpartum', 'description': 'Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression'}, {'measure': 'Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA', 'timeFrame': '2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum', 'description': 'Exclusive breastfeeding at specific time intervals postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postpartum contraception', 'Contraceptive continuation', 'Breastfeeding', 'Postpartum depression', 'Progestins'], 'conditions': ['Contraception', 'Postpartum Depression', 'Lactation']}, 'descriptionModule': {'briefSummary': 'The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.', 'detailedDescription': 'In the United States, depot medroxyprogesterone acetate (DMPA) is given to women after delivery and before hospital discharge with the belief that women who delay starting DMPA may be more likely to become pregnant when they are not yet ready to be pregnant and that giving DMPA before discharge has little to no negative effect on breastfeeding. Administering DMPA to breastfeeding women has not been widely questioned because the limited existing studies do not show any adverse impact of DMPA on breastfeeding. However, these studies used inappropriate control groups and did not control for prior lactation experience.\n\nThe investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants. The investigators will also look at rates of use of highly effective contraception (defined as DMPA, intrauterine device, implant, sterilization, or lactational amenorrhea) and postpartum depression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old and \\> 24 0/7 weeks pregnant at time of enrollment\n* Planning to deliver at Magee-Womens Hospital and to breastfeed\n* Plans to use DMPA for postpartum contraception for at least 6 months\n* Willing and able to provide informed consent in English and to comply with study protocol\n\nExclusion Criteria:\n\n* Intolerance of irregular vaginal bleeding\n* Severe coagulation disorder\n* Severe liver disease (LFTs \\>2x upper limits of normal at time of randomization)\n* Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia\n* History of breast cancer, reduction or augmentation surgery\n* History of severe clinical depression\n* Multiple gestation'}, 'identificationModule': {'nctId': 'NCT01463202', 'acronym': 'DEPO-ABCD', 'briefTitle': 'Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial', 'orgStudyIdInfo': {'id': 'SFP5-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DMPA postpartum', 'description': 'Depot medroxyprogesterone acetate postpartum', 'interventionNames': ['Drug: Depot medroxyprogesterone acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DMPA at 4-6 weeks after delivery', 'description': 'Depot medroxyprogesterone acetate at 4-6 weeks after delivery', 'interventionNames': ['Drug: Depot medroxyprogesterone acetate']}], 'interventions': [{'name': 'Depot medroxyprogesterone acetate', 'type': 'DRUG', 'otherNames': ['DMPA', 'Depo Provera'], 'description': 'Postpartum administration of DMPA (prior to hospital discharge)', 'armGroupLabels': ['DMPA postpartum']}, {'name': 'Depot medroxyprogesterone acetate', 'type': 'DRUG', 'otherNames': ['DMPA', 'Depo Provera'], 'description': 'Delayed administration of DMPA (4-6 weeks postpartum)', 'armGroupLabels': ['DMPA at 4-6 weeks after delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for Family Planning Research, Magee-Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Study Coordinator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beatrice Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Beatrice Chen', 'investigatorAffiliation': 'University of Pittsburgh'}}}}