Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-10 @ 1:48 AM
Study NCT ID:
NCT03298802
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'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': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Randomization will be performed by a person not involved in the clinical trial using a computer random list of numbers generated using STATA (StataCorp 14.0, Dallas, TX). This list of random number assignments will be kept secure and sent directly to the investigational drug service (IDS), who will be responsible for the allocation and dispensing of the medications'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blind randomized placebo controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 612}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-29', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of readmission and/or triage visits', 'timeFrame': '1-6 weeks postpartum', 'description': 'Any visit in the hospital'}, {'measure': 'Need for additional antihypertensive therapy', 'timeFrame': '1-6 weeks postpartum', 'description': 'Requiring additional antihypertensive agents in the postpartum period'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '1-6 weeks postpartum', 'description': 'Days that patient required to be in-house in the postpartum period'}, {'measure': 'Total Additional doses of anti-hypertensive therapy', 'timeFrame': '1-6 weeks postpartum', 'description': 'Addition of total doses that patient received in the postpartum period'}, {'measure': 'Elevation of blood pressure >150/90', 'timeFrame': '1-6 weeks postpartum', 'description': 'Hypertension definition in the postpartum period'}, {'measure': 'Severe composite maternal morbidity', 'timeFrame': '1-6 weeks postpartum', 'description': 'o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death'}, {'measure': 'Use of resources', 'timeFrame': '1-6 weeks postpartum', 'description': 'hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.'}, {'measure': 'Adverse Events', 'timeFrame': '1-6 weeks Postpartum', 'description': 'Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['readmission', 'triage visit for pregnancy related hypertension', 'hydrochlorothiazide'], 'conditions': ['Pre-Eclampsia', 'Gestational Hypertension', 'Superimposed Pre-Eclampsia', 'Hypertension, Pregnancy-Induced', 'Postpartum Pregnancy-Induced Hypertension', 'Postpartum Preeclampsia']}, 'descriptionModule': {'briefSummary': 'Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.', 'detailedDescription': 'To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and relapse of preeclampsia or gestational hypertension on readmission rates, need for additional antihypertensive therapy and number of triage visits.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women after delivery of neonate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal age ≥ 18 years and \\<50 years.\n* Diagnosis of gestational hypertension\\* or preeclampsia\\^ at any time during pregnancy, labor or postpartum.\n\n * defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm Hg or greater, or both) or \\^ defines as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.)\n\nExclusion Criteria:\n\n* Subject requiring antihypertensive therapy at time of screening.\n* Planned discharge with oral anti-hypertensive medication.\n* Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides).\n* Subject not able to follow up postpartum.\n* Lactose intolerance.\n* Pre-gestational diabetes.'}, 'identificationModule': {'nctId': 'NCT03298802', 'briefTitle': 'Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '16-0280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrochlorothiazide 50mg Tablet', 'description': 'Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.', 'interventionNames': ['Drug: Hydrochlorothiazide 50mg Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Tablet', 'description': 'Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum', 'interventionNames': ['Drug: Placebo Tablet']}], 'interventions': [{'name': 'Hydrochlorothiazide 50mg Tablet', 'type': 'DRUG', 'otherNames': ['HydroDIURIL, Microzide, Esidrix, Oretic'], 'description': 'Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.', 'armGroupLabels': ['Hydrochlorothiazide 50mg Tablet']}, {'name': 'Placebo Tablet', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum', 'armGroupLabels': ['Placebo Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caroline Gleason, RN', 'role': 'CONTACT', 'email': 'Caroline.Gleason@hcahealthcare.com', 'phone': '512-821-2540'}], 'facility': "St. David's North Austin Medical Center", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Bush, MD', 'role': 'CONTACT', 'email': 'babush@utmb.edu', 'phone': '409-772-1011'}], 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'centralContacts': [{'name': 'Megan C Shepherd, M.D.', 'role': 'CONTACT', 'email': 'mcshephe@UTMB.EDU', 'phone': '409-772-0312'}, {'name': 'Ashley Salazar, RN', 'role': 'CONTACT', 'email': 'assalaza@utmb.edu', 'phone': '409-772-0312'}], 'overallOfficials': [{'name': 'Benjamin Bush, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}