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Futility of the study
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Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrochlorothiazide 50mg Tablet | Active Comparator | 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. |
|
| Placebo Tablet | Placebo Comparator | Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide 50mg Tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Required Re-Admission or Triage Visit | Any participants who had a visit to the hospital during the 1-6 weeks postpartum. | 1-6 weeks postpartum |
| Number of Participants That Need Additional Antihypertensive Therapy | Number of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window | 1-6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Days that participants required to be in-house in the postpartum period | 1-6 weeks postpartum |
| Total Additional Doses of Anti-hypertensive Therapy | Number of participants that receive one additional doses in the 1-6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Resources | Number of participants that had additional Hospital Stay, Postpartum Clinic or Emergency room visit, Need for Imaging or other Invasive Procedures within 4-6 weeks of delivery, 4-6 weeks postpartum. | 1-6 weeks postpartum |
Inclusion Criteria:
Maternal age ≥ 18 years and <50 years.
Diagnosis of gestational hypertension* or preeclampsia^ at any time during pregnancy, labor or postpartum.
Exclusion Criteria:
Women after delivery of neonate
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Bush, M.D. | UTMB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. David's North Austin Medical Center | Austin | Texas | 78758 | United States | ||
| University of Texas Medical Branch |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrochlorothiazide 50mg Tablet | 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. Hydrochlorothiazide 50mg Tablet: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2023 |
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double-blind randomized placebo controlled clinical trial
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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
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| Placebo Tablet | Drug | 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 |
|
|
| 1-6 weeks postpartum |
| Elevation of Blood Pressure >150/90 | Number of participants that have a blood pressure greater than 150/90 in the 1-6 weeks postpartum window | 1-6 weeks postpartum |
| Severe Composite Maternal Morbidity | Number of participants with any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death. | 1-6 weeks postpartum |
| Adverse Events | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis) | 1-6 weeks Postpartum |
| Galveston |
| Texas |
| 77555 |
| United States |
| FG001 | Placebo Tablet | Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum Placebo Tablet: 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrochlorothiazide 50mg Tablet and Placebo Tablet | 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. Hydrochlorothiazide 50mg Tablet: 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. |
| BG001 | Placebo Tablet | Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum Placebo Tablet: 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Required Re-Admission or Triage Visit | Any participants who had a visit to the hospital during the 1-6 weeks postpartum. | Posted | Count of Participants | Participants | 1-6 weeks postpartum |
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| ||||||||||||||||||||||||||||||
| Primary | Number of Participants That Need Additional Antihypertensive Therapy | Number of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window | Posted | Count of Participants | Participants | 1-6 weeks postpartum |
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| Secondary | Length of Hospital Stay | Days that participants required to be in-house in the postpartum period | Posted | Mean | Standard Deviation | days | 1-6 weeks postpartum |
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| Secondary | Total Additional Doses of Anti-hypertensive Therapy | Number of participants that receive one additional doses in the 1-6 weeks postpartum | Posted | Count of Participants | Participants | 1-6 weeks postpartum |
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| |||||||||||||||||||||||||||||||
| Secondary | Elevation of Blood Pressure >150/90 | Number of participants that have a blood pressure greater than 150/90 in the 1-6 weeks postpartum window | Posted | Count of Participants | Participants | 1-6 weeks postpartum |
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| |||||||||||||||||||||||||||||||
| Secondary | Severe Composite Maternal Morbidity | Number of participants with any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death. | Posted | Count of Participants | Participants | 1-6 weeks postpartum |
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| |||||||||||||||||||||||||||||||
| Secondary | Adverse Events | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis) | Posted | Count of Participants | Participants | 1-6 weeks Postpartum |
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| |||||||||||||||||||||||||||||||
| Other Pre-specified | Use of Resources | Number of participants that had additional Hospital Stay, Postpartum Clinic or Emergency room visit, Need for Imaging or other Invasive Procedures within 4-6 weeks of delivery, 4-6 weeks postpartum. | Posted | Count of Participants | Participants | 1-6 weeks postpartum |
|
|
1-6 weeks postpartum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrochlorothiazide 50mg Tablet | 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. Hydrochlorothiazide 50mg Tablet: 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. | 0 | 196 | 1 | 196 | 1 | 196 |
| EG001 | Placebo Tablet | Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum Placebo Tablet: 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 | 0 | 196 | 0 | 196 | 1 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Admission | Gastrointestinal disorders | Systematic Assessment | Admitted to the hospital. She has Cholelithiasis possible choledocholithiasis. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient diagnosed with Pyelonephritis and urosepsis | Renal and urinary disorders | Systematic Assessment | Patient diagnosed with Pyelonephritis and urosepsis. Clindamycin IV, Vancomycin IV, Ampicillin IV, plan for PO antibiotics upon discharge. Pre E w/ Severe features requiring PO anti-hypertensives Nifedipine. In order for subject to be correctly tr |
| |
| Allergic Reaction | Immune system disorders | Systematic Assessment | After taking investigational drug (placebo or Drug) , the subject developed facial swelling and rash over cheeks, with itching. Drug was stopped and patient received Benadryl and rash resolved. This event did not increase length of stay |
|
The study began in 2016 and underwent multiple Principal Investigator (PI) transitions. The data provided represents the information currently available to the study team.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corey Clifford, DO | UTMB | 409-772-0312 | cccliffo@utmb.edu |
| Sep 30, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| D013607 | Tablets |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002241 | Carbohydrates |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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