Pre-EclampsiaPhase 3NCT03298802
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
A Phase 3 study testing Hydrochlorothiazide 50mg Tablet in people with Pre-Eclampsia and Gestational Hypertension, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pre-Eclampsia, Gestational Hypertension, Superimposed Pre-Eclampsia
- What is being tested?
- Hydrochlorothiazide 50mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 453 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2017to 22 Apr 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age ≥ 18 years and <50 years.
- Diagnosis of gestational hypertension* or preeclampsia^ at any time during pregnancy, labor or postpartum.
- 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.)
Who cannot join
- Subject requiring antihypertensive therapy at time of screening.
- Planned discharge with oral anti-hypertensive medication.
- Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides).
- Subject not able to follow up postpartum.
- Lactose intolerance.
- Pre-gestational diabetes.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. David's North Austin Medical Center
Austin, Texas, 78758
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
Read the detailed description
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.
- Conditions
- Pre-Eclampsia, Gestational Hypertension, Superimposed Pre-Eclampsia, Hypertension, Pregnancy-Induced, Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia
- Being tested
- Hydrochlorothiazide 50mg Tablet, Placebo Tablet
- Keywords
- readmission, triage visit for pregnancy related hypertension, hydrochlorothiazide
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrochlorothiazide 50mg TabletDrug
Also called HydroDIURIL, Microzide, Esidrix, Oretic
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 TabletDrug
Also called sugar pill
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hydrochlorothiazide 50mg Tablet |
| 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 Receives: Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Required Re-Admission or Triage Visit
Any participants who had a visit to the hospital during the 1-6 weeks postpartum.
Measured: 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
Measured: 1-6 weeks postpartum
Secondary outcomes (5)
Length of Hospital Stay
Days that participants required to be in-house in the postpartum period
Measured: 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
Measured: 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
Measured: 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.
Measured: 1-6 weeks postpartum
Adverse Events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
Measured: 1-6 weeks Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start21 Nov 2017
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Why it stopped: Futility of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind randomized placebo controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Bush, M.D., Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298802
- Sponsor's protocol ID
- 16-0280
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2017
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03298802
- Acronym / sponsor ID
- 16-0280
- Conditions
- Pre-Eclampsia, Gestational Hypertension, Superimposed Pre-Eclampsia, Hypertension, Pregnancy-Induced, Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia
- Keywords
- readmission, triage visit for pregnancy related hypertension, hydrochlorothiazide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility of the study
- Enrolment
- 453 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blind randomized placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hydrochlorothiazide 50mg Tablet | Active comparator | Drug: Hydrochlorothiazide 50mg TabletHydrochlorothiazide 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 | Drug: Placebo TabletPlacebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Maternal age ≥ 18 years and <50 years.
- Diagnosis of gestational hypertension* or preeclampsia^ at any time during pregnancy, labor or postpartum.
Key exclusion criteria (6 listed)
- Subject requiring antihypertensive therapy at time of screening.
- Planned discharge with oral anti-hypertensive medication.
- Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides).
- Subject not able to follow up postpartum.
- Lactose intolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrochlorothiazide 50mg TabletAlso: HydroDIURIL, Microzide, Esidrix, OreticHydrochlorothiazide 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 TabletAlso: sugar pillPlacebo 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 | Placebo Tablet |
Primary outcome
Number of Participants Required Re-Admission or Triage Visit
Time frame: 1-6 weeks postpartum
Any participants who had a visit to the hospital during the 1-6 weeks postpartum.
Number of Participants That Need Additional Antihypertensive Therapy
Time frame: 1-6 weeks postpartum
Number of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window
5 secondary outcomes
Length of Hospital Stay
Time frame: 1-6 weeks postpartum
Total Additional Doses of Anti-hypertensive Therapy
Time frame: 1-6 weeks postpartum
Elevation of Blood Pressure >150/90
Time frame: 1-6 weeks postpartum
Severe Composite Maternal Morbidity
Time frame: 1-6 weeks postpartum
Adverse Events
Time frame: 1-6 weeks Postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Bush, M.D. principal investigator
UTMB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrochlorothiazide 50mg Tablet in people with Pre-Eclampsia and Gestational Hypertension, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Required Re-Admission or Triage Visit (time frame: 1-6 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.