Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT03136068
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2017-02-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abby.sokoloff@ucsf.edu', 'phone': '414-206-8715', 'title': 'Director of Clinical Trials', 'organization': 'UCSF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'two days, day one and day two', 'description': 'does not differ from clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 7, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 3, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'pregnancy labor', 'notes': 'patient went into labor prior to D\\&E (Dilation and evacuation), had D\\&C (Dilation and curettage)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'severe nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hemmorhage', 'notes': '1 post-D\\&E hemorrhage (requiring vag pack and med tx)\n\n1 intra-op hemorrhage requiring Foley and med tx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety', 'notes': 'severe anxiety/pain post D\\&E requiring medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cramping', 'notes': 'extreme cramping pain following injection severe cramping pain post D\\&E requiring medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mass', 'notes': 'MD identified uterine mass, pt transferred to hospital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'notes': 'extreme nausea/vomiting following injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'blood transfusion', 'notes': 'Post-D\\&E hemorrhage, patient admitted for transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procedure Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Beginning to end of procedure (between 5 minutes and 1 hour)', 'description': 'First instrument into uterus until procedure complete', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of procedure time from speculum insertion to procedure completion'}, {'type': 'SECONDARY', 'title': 'Total Procedure Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'done on Day 2 during the procedure', 'description': 'Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'duration of procedure for each participant from insertion of speculum to total procedure completion, including any post-procedure activities prior to being taken to recovery'}, {'type': 'SECONDARY', 'title': 'Measured Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '417', 'groupId': 'OG000', 'lowerLimit': '305', 'upperLimit': '527'}, {'value': '363', 'groupId': 'OG001', 'lowerLimit': '279', 'upperLimit': '522'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 2, during the procedure', 'description': 'measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'measured blood loss was only completed at the Zuckerberg San Francisco General Hospital location, which is why the total is 61 rather than 175 for this outcome'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Reported Fetal Death Prior to Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2, before procedure', 'description': 'number of patients who had fetal death measured by ultrasound', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number of patients who had reported fetal death on day 2'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2', 'description': 'hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'any complication reported by patient; may have reported more than one complication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance\n\nDigoxin: Trans-abdominal injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume\n\nPlacebo: Trans-abdominal injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '26.2', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '26.8', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '178', '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': 'Caucasian, non-Hispanic', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'African-American, non-Hispanic', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Mixed/Multi', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '26.7', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nulliparous', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational duration', 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '22'}, {'value': '21.0', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '21.0', 'groupId': 'BG002', 'lowerLimit': '20.4', 'upperLimit': '21.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-13', 'size': 401294, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-09T16:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2017-02-06', 'resultsFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-09', 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Duration', 'timeFrame': 'Beginning to end of procedure (between 5 minutes and 1 hour)', 'description': 'First instrument into uterus until procedure complete'}], 'secondaryOutcomes': [{'measure': 'Total Procedure Duration', 'timeFrame': 'done on Day 2 during the procedure', 'description': 'Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything'}, {'measure': 'Measured Blood Loss', 'timeFrame': 'Day 2, during the procedure', 'description': 'measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood'}, {'measure': 'Number of Patients With Reported Fetal Death Prior to Procedure', 'timeFrame': 'Day 2, before procedure', 'description': 'number of patients who had fetal death measured by ultrasound'}, {'measure': 'Complications', 'timeFrame': 'Day 2', 'description': 'hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abortion']}, 'descriptionModule': {'briefSummary': 'This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D\\&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D\\&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D\\&E procedure, but doctors want to clarify how digoxin effects D\\&E procedure time, if at all.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 weeks 0 days-24 weeks 0 days gestation\n* English or Spanish speaking\n* 18 years or older\n\nExclusion Criteria:\n\n* Under 18\n* Contraindications to digoxin'}, 'identificationModule': {'nctId': 'NCT03136068', 'briefTitle': "Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation", 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': "Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'Digoxin RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digoxin', 'description': 'Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance', 'interventionNames': ['Drug: Digoxin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Digoxin', 'type': 'DRUG', 'description': 'Trans-abdominal injection', 'armGroupLabels': ['Digoxin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Trans-abdominal injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "FPA Women's Health", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "SFGH Women's Options Center", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Lovejoy Surgicenter', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': "FPA Women's Health", 'class': 'UNKNOWN'}, {'name': 'Society of Family Planning', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor department of Obstetrics, Gynecology and Reproductive Sciences', 'investigatorFullName': 'Jennifer Kerns, MD, MS, MPH', 'investigatorAffiliation': 'University of California, San Francisco'}}}}