Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-04 @ 4:20 PM
Study NCT ID:
NCT03556761
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2018-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Furosemide for Accelerated Recovery of Blood Pressure Postpartum
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisa.levine@pennmedicine.upenn.edu', 'phone': '215-662-6913', 'title': 'Dr Lisa Levine', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Over 6 weeks postpartum', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 3, 'seriousNumAtRisk': 192, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 1, 'seriousNumAtRisk': 192, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pulmonary edema', 'notes': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Persistently Elevated Blood Pressures 7 Days Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.81', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-7 days postpartum', 'description': 'To compare the rate of persistently elevated blood pressures (\\>140/90) in women that receive a five day furosemide course compared to those that receive placebo.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '6.25', 'upperLimit': '12.5'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '12.5'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.51', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0-14 days postpartum', 'description': 'To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postpartum Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.21', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of subjects with one or more readmission/ER visit that were hypertension related', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Had Severe Hypertension Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.18', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of women who had severe hypertension (systolic blood pressure\\>160 millimeters of mercury or diastolic blood pressure\\>110 millimeters of mercury) postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postpartum Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '.13', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of days postpartum participants stayed in the hospital', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects With Complications During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-6 weeks postpartum', 'description': 'Subjects with complications during hospitalization related to hypertensive disorders of pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Experiencing One or More Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3', 'ciLowerLimit': '0.32', 'ciUpperLimit': '28.59', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of subjects experiencing one or more adverse effects secondary to furosemide', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects That Required for Additional Antihypertensives', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'OG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.96', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 6 weeks post-partum', 'description': 'Number of subjects that required additional hypertensive medication after discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.\n\nOral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily'}, {'id': 'FG001', 'title': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.\n\nPlacebo Oral Tablet: Placebo, PO, daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Furosemide', 'description': 'Oral tablet of furosemide 20 mg once daily for a total of 5 consecutive doses.'}, {'id': 'BG001', 'title': 'Placebo Oral Tablet', 'description': 'Oral tablet of placebo once daily for a total of 5 consecutive doses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '32'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '33'}, {'value': '27', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '384', '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': 'Black', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertensive Disorders of Pregnancy (HDP)', 'classes': [{'categories': [{'title': 'Non-severe', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at delivery', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'groupId': 'BG000', 'lowerLimit': '37.3', 'upperLimit': '39.7'}, {'value': '38.4', 'groupId': 'BG001', 'lowerLimit': '37.3', 'upperLimit': '39.7'}, {'value': '38.5', 'groupId': 'BG002', 'lowerLimit': '37.3', 'upperLimit': '39.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Cesarean delivery', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-19', 'size': 258664, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-01T10:54', 'hasProtocol': True}, {'date': '2018-09-13', 'size': 225643, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-01T10:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study medication (furosemide) and placebo will be stored at room temperature at the University of Pennsylvania research pharmacy. Pharmacy will be responsible for labeling and randomizing the medications.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind, randomized, placebo control design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2018-06-01', 'resultsFirstSubmitDate': '2020-08-02', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-26', 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistently Elevated Blood Pressures 7 Days Postpartum', 'timeFrame': '0-7 days postpartum', 'description': 'To compare the rate of persistently elevated blood pressures (\\>140/90) in women that receive a five day furosemide course compared to those that receive placebo.'}, {'measure': 'Time to Resolution', 'timeFrame': '0-14 days postpartum', 'description': 'To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.'}], 'secondaryOutcomes': [{'measure': 'Postpartum Readmission', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of subjects with one or more readmission/ER visit that were hypertension related'}, {'measure': 'Number of Subjects Who Had Severe Hypertension Postpartum', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of women who had severe hypertension (systolic blood pressure\\>160 millimeters of mercury or diastolic blood pressure\\>110 millimeters of mercury) postpartum'}, {'measure': 'Postpartum Length of Stay', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of days postpartum participants stayed in the hospital'}, {'measure': 'Subjects With Complications During Hospitalization', 'timeFrame': '0-6 weeks postpartum', 'description': 'Subjects with complications during hospitalization related to hypertensive disorders of pregnancy.'}, {'measure': 'Number of Subjects Experiencing One or More Adverse Effects', 'timeFrame': '0-6 weeks postpartum', 'description': 'Number of subjects experiencing one or more adverse effects secondary to furosemide'}, {'measure': 'Number of Subjects That Required for Additional Antihypertensives', 'timeFrame': '0 to 6 weeks post-partum', 'description': 'Number of subjects that required additional hypertensive medication after discharge'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Furosemide', 'Postpartum', 'Hypertension'], 'conditions': ['Hypertension, Pregnancy-Induced']}, 'referencesModule': {'references': [{'pmid': '33550824', 'type': 'DERIVED', 'citation': 'Lopes Perdigao J, Lewey J, Hirshberg A, Koelper N, Srinivas SK, Elovitz MA, Levine LD. Furosemide for Accelerated Recovery of Blood Pressure Postpartum in women with a hypertensive disorder of pregnancy: A Randomized Controlled Trial. Hypertension. 2021 May 5;77(5):1517-1524. doi: 10.1161/HYPERTENSIONAHA.120.16133. Epub 2021 Feb 8.'}]}, 'descriptionModule': {'briefSummary': "A randomized, double-blind, placebo-controlled single center investigation of furosemide's effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders of pregnancy", 'detailedDescription': 'Hypertensive disorders of pregnancy are recognized causes of significant maternal/fetal morbidity and mortality, accounting for approximately 18% of maternal deaths worldwide. While significant research has been done on the evaluation and management of hypertension during pregnancy, studies of postpartum hypertension (PPHTN) are usually limited by their retrospective design and focus on inpatients in the immediate postpartum period (2-6 days), or patients who were readmitted due to complications related to hypertension. Few studies have investigated the incidence and proper management of hypertension in the postpartum period. Furthermore, in the United Kingdom, a review of maternal deaths determined that 10% were related to hypertensive disorders in pregnancy (HDP) in the postpartum period. Postpartum hypertension is also the cause of approximately 27% of readmissions to the hospital. These studies clearly show that PPHTN is associated with significant morbidity and that it is important to develop interventions that can reduce its effects.\n\nIn patients with HDP, postpartum blood pressure has been shown to decrease in the first 48 hours postpartum only to then increase in days 3-6 postpartum. This phenomenon is thought to be secondary to large fluid shifts, both secondary from fluid retention during the pregnant state as well as from fluids given intrapartum. Furthermore, large volumes of sodium are also mobilized into the intravascular compartment at this time. Given the latter, furosemide, a loop diuretic that mobilizes sodium and fluid excretion has been posed as a method to prevent severe range blood pressures and their associated maternal morbidity in the postpartum period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum\n* Gestational hypertension\n* Pre-eclampsia with or without severe features\n* Superimposed pre-eclampsia with or without severe features\n* New diagnosis of HDP within 24 hours from delivery\n* Postpartum, delivery ≥ 20 weeks estimated gestational age\n* Age ≥18 years old\n\nExclusion Criteria:\n\n* History of allergic reaction to furosemide\n* High risk comorbidities for which treatment may be indicated or contraindicated: class C or higher diabetes mellitus, chronic kidney disease or baseline creatinine \\>1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease\n* Baseline labs with K \\<3\n* Use of furosemide or other diuretics antepartum or intrapartum\n* Use of ototoxic agents including aminoglycosides (ie, Gentamicin for \\>1 dose), cephalosporins (ie Ancef \\>1 dose),\n* Patient unstable for protocol per investigator's judgement"}, 'identificationModule': {'nctId': 'NCT03556761', 'acronym': 'ForBP', 'briefTitle': 'Furosemide for Accelerated Recovery of Blood Pressure Postpartum', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Furosemide for Accelerated Recovery of Blood Pressure Postpartum', 'orgStudyIdInfo': {'id': '829444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral furosemide', 'description': 'Oral furosemide 20 mg/day for a total of 5 consecutive doses.', 'interventionNames': ['Drug: Oral furosemide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Tablet', 'description': 'Placebo once per day for a total of 5 consecutive doses.', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Oral furosemide', 'type': 'DRUG', 'description': 'Furosemide (Lasix), 20 milligram, PO, PO, daily', 'armGroupLabels': ['Oral furosemide']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Placebo, PO, daily', 'armGroupLabels': ['Placebo Oral Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Lisa Levine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lisa Levine', 'investigatorAffiliation': 'University of Pennsylvania'}}}}