Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 12:15 PM
Study NCT ID:
NCT04236258
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004656', 'term': 'Enalapril'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eyoselevsky@bwh.harvard.edu', 'phone': '314-413-1254', 'title': 'Dr. Elizabeth Yoselevsky', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial was conducted during the COVID pandemic which fundamentally changed the way patients interact with the medical system.'}}, 'adverseEventsModule': {'timeFrame': 'Data were collected for each patient over a period of 6 weeks after their delivery.', 'eventGroups': [{'id': 'EG000', 'title': 'Nifedipine', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.\n\nNifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enalapril', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.\n\nEnalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prolonged Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.\n\nNifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.\n\nEnalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Unscheduled Clinic Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Participants in the nifedipine group were assigned nifedipine ER 30mg daily as their initial antihypertensive.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Participants in the nifedipine group were assigned enalapril 10mg daily as their initial antihypertensive.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visit to Labor and Delivery Triage for Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Participants in the nifedipine group were assigned nifedipine ER 30mg daily as their initial antihypertensive.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Participants in the nifedipine group were assigned enalapril 10mg daily as their initial antihypertensive.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Postpartum Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Participants in the nifedipine group were assigned nifedipine ER 30mg daily as their initial antihypertensive.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Participants in the nifedipine group were assigned enalapril 10mg daily as their initial antihypertensive.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to six weeks postpartum', 'description': 'Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for \\>24 hours)', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Needed for Additional Antihypertensives', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'Any time a patient needs a second or third agent added to her antihypertensive regimen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to six weeks postpartum', 'description': 'The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Hypotension or Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'Any time a patient became symptomatic from her blood pressure as noted by her providers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Creatinine Values at 1-2 Weeks After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': 'Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This is the population of participants who attended a 1-2 week clinic visit after discharge and had a creatinine level drawn'}, {'type': 'SECONDARY', 'title': 'Continued Need for Antihypertensive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'If a patient still needs the prescribed antihypertensives one week after discharge and six weeks after delivery to control her blood pressure as determined by her provider during her clinic visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Self-reported Compliance With Their Antihypertensive Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Patients who were initially randomized to nifedipine'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Patients who were initially randomized to enalapril'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to six weeks postpartum', 'description': 'The patient will complete a survey that self-assesses how compliant she has been with taking the prescribed antihypertensives ("difficulty remembering to take the medication")', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Creatinine Level Around 6 Weeks After Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.\n\nNifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.\n\nEnalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after delivery', 'description': 'Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This is the population who attended their 6 week postpartum visit and had a creatinine level drawn at that time'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nifedipine', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.\n\nNifedipine ER: Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.'}, {'id': 'FG001', 'title': 'Enalapril', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.\n\nEnalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'We enrolled 94 participants in the study.', 'preAssignmentDetails': 'We aimed for 90 participants as part of the protocol but ended up oversampling at 94 due to concern over potential drop out.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nifedipine', 'description': 'Participants in the nifedipine group were assigned nifedipine ER 30mg daily as their initial antihypertensive.'}, {'id': 'BG001', 'title': 'Enalapril', 'description': 'Participants in the nifedipine group were assigned enalapril 10mg daily as their initial antihypertensive.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'all participants in the study were female', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This is self-identified race and/or ethnicity as derived from the electronic medical record.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insurance', 'classes': [{'categories': [{'title': 'Public insurance', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Private insurance', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '1.89', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '1.85', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '1.87', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'number of live children a participant has', 'unitOfMeasure': 'para', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Twin gestation', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Delivery type', 'classes': [{'categories': [{'title': 'Vaginal', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Operative', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Cesarean', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at delivery', 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '37.4', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hypertensive diagnosis', 'classes': [{'categories': [{'title': 'Chronic', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Gestational', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Preeclampsia without severe features', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Preeclampsia with severe features', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Superimposed preeclampsia', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '35.2', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-03', 'size': 333620, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-28T13:38', 'hasProtocol': True}, {'date': '2022-01-03', 'size': 100284, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-28T13:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2020-01-16', 'resultsFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-10', 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolonged Hospitalization', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery'}, {'measure': 'Unscheduled Clinic Appointment', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled'}, {'measure': 'Visit to Labor and Delivery Triage for Evaluation', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason'}, {'measure': 'Postpartum Readmission', 'timeFrame': 'up to six weeks postpartum', 'description': 'Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period'}], 'secondaryOutcomes': [{'measure': 'Time to Blood Pressure Control', 'timeFrame': 'up to six weeks postpartum', 'description': 'Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for \\>24 hours)'}, {'measure': 'Number of Participants Who Needed for Additional Antihypertensives', 'timeFrame': 'up to six weeks postpartum', 'description': 'Any time a patient needs a second or third agent added to her antihypertensive regimen'}, {'measure': 'Time to Discharge', 'timeFrame': 'up to six weeks postpartum', 'description': 'The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension'}, {'measure': 'Clinically Significant Hypotension or Hypertension', 'timeFrame': 'up to six weeks postpartum', 'description': 'Any time a patient became symptomatic from her blood pressure as noted by her providers'}, {'measure': 'Creatinine Values at 1-2 Weeks After Discharge', 'timeFrame': '1-2 weeks', 'description': 'Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)'}, {'measure': 'Continued Need for Antihypertensive', 'timeFrame': 'up to six weeks postpartum', 'description': 'If a patient still needs the prescribed antihypertensives one week after discharge and six weeks after delivery to control her blood pressure as determined by her provider during her clinic visit'}, {'measure': 'Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received', 'timeFrame': 'up to six weeks postpartum', 'description': 'A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication'}, {'measure': 'Patient Self-reported Compliance With Their Antihypertensive Regimen', 'timeFrame': 'up to six weeks postpartum', 'description': 'The patient will complete a survey that self-assesses how compliant she has been with taking the prescribed antihypertensives ("difficulty remembering to take the medication")'}, {'measure': 'Creatinine Level Around 6 Weeks After Delivery', 'timeFrame': '6 weeks after delivery', 'description': 'Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension in Pregnancy', 'Preeclampsia Severe', 'Gestational Hypertension', 'Postpartum Preeclampsia', 'Postpartum']}, 'referencesModule': {'references': [{'pmid': '37806651', 'type': 'DERIVED', 'citation': 'Yoselevsky EM, Seely EW, Celi AC, Robinson JN, McElrath TF. A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101178. doi: 10.1016/j.ajogmf.2023.101178. Epub 2023 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. We will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.', 'detailedDescription': "This is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. These are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital.\n\nNifedipine is more traditionally used and well-validated by current medical literature. However, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. Therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used in the postpartum period."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension\n* provider wanting to initiate antihypertensive in the postpartum period\n* the patient is not currently on \\>1 antihypertensive\n* plans to receive postpartum care at the hospital or affiliated clinic\n\nExclusion Criteria:\n\n* sustained pulse \\<60 or \\>120 BPM over four hours\n* allergy to any of the antihypertensives\n* creatinine greater than or equal to 1.5\n* strict contraindication to any of the antihypertensives\n* history of failed treatment with any of the antihypertensives'}, 'identificationModule': {'nctId': 'NCT04236258', 'briefTitle': 'Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period', 'orgStudyIdInfo': {'id': '2019P002981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nifedipine', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.', 'interventionNames': ['Drug: NIFEdipine ER']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril', 'description': 'This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.', 'interventionNames': ['Drug: Enalapril']}], 'interventions': [{'name': 'NIFEdipine ER', 'type': 'DRUG', 'description': 'Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.', 'armGroupLabels': ['Nifedipine']}, {'name': 'Enalapril', 'type': 'DRUG', 'description': 'Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.', 'armGroupLabels': ['Enalapril']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Thomas McElrath, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': "The data will be available for approximately six months after the study's conclusion.", 'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.', 'accessCriteria': 'Data access requests will be reviewed by the internal Institutional Review Board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas Frederick McElrath, M.D.,Ph.D.', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}