A Phase 3 interventional study of Hydrochlorothiazide 50mg Tablet and Placebo Tablet in Pre-Eclampsia, Gestational Hypertension and Superimposed Pre-Eclampsia, sponsored by The University of Texas Medical Branch, Galveston. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by The University of Texas Medical Branch, Galveston · Phase 3, Interventional, and Prevention
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.
Diagnosis of gestational hypertension* or preeclampsia\^ at any time during pregnancy, labor or postpartum.
Exclusion Criteria:
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.
Drug: Hydrochlorothiazide 50mg Tablet
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum
Drug: 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.
Also known as: HydroDIURIL, Microzide, Esidrix, Oretic
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
Also known as: sugar pill
Number of Participants Required Re-Admission or Triage Visit
Any participants who had a visit to the hospital during the 1-6 weeks postpartum.
Time frame: 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
Time frame: 1-6 weeks postpartum
Length of Hospital Stay
Days that participants required to be in-house in the postpartum period
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 1-6 weeks postpartum
Adverse Events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
Time frame: 1-6 weeks Postpartum
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.
Time frame: 1-6 weeks postpartum
| Milestone | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Started | 201 | 199 |
| Completed | 196 | 196 |
| Not completed | 5 | 3 |
Any participants who had a visit to the hospital during the 1-6 weeks postpartum.
| Participants | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Number of Participants Required Re-Admission or Triage Visit | 3 | 10 |
Number of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window
| Participants | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Number of Participants That Need Additional Antihypertensive Therapy | 6 | 6 |
Days that participants required to be in-house in the postpartum period
| days | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Length of Hospital Stay | 2.25 ± 0.93 | 2.18 ± 0.57 |
Number of participants that receive one additional doses in the 1-6 weeks postpartum
| Participants | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Total Additional Doses of Anti-hypertensive Therapy | 6 | 6 |
Number of participants that have a blood pressure greater than 150/90 in the 1-6 weeks postpartum window
| Participants | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Elevation of Blood Pressure >150/90 | 21 | 15 |
Number of participants with any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death.
| Participants | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| ICU admission | 0 | 0 |
| HELLP syndrome | 0 | 0 |
| Eclampsia | 0 | 0 |
| Maternal Death | 0 | 0 |
| Cardiomyopathy | 0 | 0 |
| Pulmonary edema | 0 | 0 |
| Renal failure | 0 | 0 |
| Stroke | 0 | 0 |
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
| Participants | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Anaphylaxis | 0 | 0 |
| Angioedema | 0 | 0 |
| Skin Rashes Including Stevens Johnson | 0 | 0 |
| Skin Rashes Including Toxic Epidermal Necrolysis | 0 | 0 |
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.
| Participants | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Additional Hospital Stay | 1 | 0 |
| Clinic or Emergency room visit | 0 | 0 |
| Need for Imaging | 0 | 0 |
| Need for other Invasive Procedures | 0 | 0 |
Collected over 1-6 weeks postpartum. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hydrochlorothiazide 50mg Tablet | 0/196 (0%) | 1/196 (0.5%) | 1/196 (0.5%) |
| Placebo Tablet | 0/196 (0%) | 0/196 (0%) | 1/196 (0.5%) |
| Event | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Hospital AdmissionGastrointestinal disorders | 1/196 | 0/196 |
| Event | Hydrochlorothiazide 50mg Tablet | Placebo Tablet |
|---|---|---|
| Patient diagnosed with Pyelonephritis and urosepsisRenal and urinary disorders | 1/196 | 0/196 |
| Allergic ReactionImmune system disorders | 0/196 | 1/196 |
| Age, Categorical(Participants) | Hydrochlorothiazide 50mg Tablet | Placebo Tablet | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 201 | 199 | 400 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Hydrochlorothiazide 50mg Tablet | Placebo Tablet | Total |
|---|---|---|---|
| Female | 201 | 199 | 400 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Hydrochlorothiazide 50mg Tablet | Placebo Tablet | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 30 | 21 | 51 |
| White | 168 | 175 | 343 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Hydrochlorothiazide 50mg Tablet | Placebo Tablet | Total |
|---|---|---|---|
| United States | 201 | 199 | 400 |
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The University of Texas Medical Branch, Galveston