ClinicalTrials.gg
TerminatedNCT03298802Updated Jul 14, 2026Results posted

Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

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

Why this study was terminated
Futility of the study

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Phase
Phase 3
Study type
Interventional
Enrollment
453
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 229 studies in Pre-Eclampsia with a site in United States — 61 open to participants now, 77 under way, 6 of them phase 3. Pre-Eclampsia · United States.

Enrollment
18th of 160
453 · median 88
Started
2017
with 14 others
Phase 3
12 of 229
4 open now
Registered
88th of 229
by date

Among the 229 studies in Pre-Eclampsia with a site in United States, this one is the 18th largest by enrollment of the 160 interventional ones that give a count, is one of 15 that started in 2017, is one of 12 in phase 3, and was the 88th registered.

Pre-Eclampsia

917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.

Browse Pre-Eclampsia studies →

Open to participants now

61 of the 229 studies in Pre-Eclampsia with a site in United States are open now. Recruiting first, the newest first:

56 more — sign in →

All 61 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.

This study: 18 Years to 50 Years · female · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ( 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.)

Exclusion criteria

Exclusion Criteria:

  • Subject requiring antihypertensive therapy at time of screening.
  • Planned discharge with oral anti-hypertensive medication.
  • to hydrochlorothiazide (advanced renal failure or anuria, to sulfonamides).
  • Subject not able to follow up postpartum.
  • Lactose intolerance.
  • Pre-gestational diabetes.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
453 participants (actual)

Study arms

  • Active comparator
    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.

    Drug: Hydrochlorothiazide 50mg Tablet

  • Placebo comparator
    Placebo 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

Interventions

  • 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

  • DrugPlacebo 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

    Also known as: sugar pill

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Length of Hospital Stay

    Days that participants required to be in-house in the postpartum period

    Time frame: 1-6 weeks postpartum

  2. 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

  3. 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

  4. 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

  5. Adverse Events

    Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)

    Time frame: 1-6 weeks Postpartum

Other outcomes

  1. 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

07

Results

Posted Jun 24, 2026
Limitations and caveats
The study began in 2016 and underwent multiple Principal Investigator (PI) transitions. All study data have now been fully identified, verified, and reported in this final dataset.

Participant flow

Participant flow — Overall Study
MilestoneHydrochlorothiazide 50mg TabletPlacebo Tablet
Started201199
Completed196196
Not completed53

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Required Re-Admission or Triage Visit
ParticipantsHydrochlorothiazide 50mg TabletPlacebo Tablet
Number of Participants Required Re-Admission or Triage Visit310
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants That Need Additional Antihypertensive Therapy
ParticipantsHydrochlorothiazide 50mg TabletPlacebo Tablet
Number of Participants That Need Additional Antihypertensive Therapy66
SecondaryLength of Hospital Stay

Days that participants required to be in-house in the postpartum period

Time frame:
1-6 weeks postpartum
Reported as:
Mean · days
Length of Hospital Stay
daysHydrochlorothiazide 50mg TabletPlacebo Tablet
Length of Hospital Stay2.25 ± 0.932.18 ± 0.57
SecondaryTotal 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
Reported as:
Count of participants · Participants
Total Additional Doses of Anti-hypertensive Therapy
ParticipantsHydrochlorothiazide 50mg TabletPlacebo Tablet
Total Additional Doses of Anti-hypertensive Therapy66
SecondaryElevation 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
Reported as:
Count of participants · Participants
Elevation of Blood Pressure >150/90
ParticipantsHydrochlorothiazide 50mg TabletPlacebo Tablet
Elevation of Blood Pressure >150/902115
SecondarySevere 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
Reported as:
Count of participants · Participants
Severe Composite Maternal Morbidity
ParticipantsHydrochlorothiazide 50mg TabletPlacebo Tablet
ICU admission00
HELLP syndrome00
Eclampsia00
Maternal Death00
Cardiomyopathy00
Pulmonary edema00
Renal failure00
Stroke00
SecondaryAdverse Events

Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)

Time frame:
1-6 weeks Postpartum
Reported as:
Count of participants · Participants
Adverse Events
ParticipantsHydrochlorothiazide 50mg TabletPlacebo Tablet
Anaphylaxis00
Angioedema00
Skin Rashes Including Stevens Johnson00
Skin Rashes Including Toxic Epidermal Necrolysis00
Other pre-specifiedUse 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
Reported as:
Count of participants · Participants
Use of Resources
ParticipantsHydrochlorothiazide 50mg TabletPlacebo Tablet
Additional Hospital Stay10
Clinic or Emergency room visit00
Need for Imaging00
Need for other Invasive Procedures00

Adverse events

Collected over 1-6 weeks postpartum. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hydrochlorothiazide 50mg Tablet0/196 (0%)1/196 (0.5%)1/196 (0.5%)
Placebo Tablet0/196 (0%)0/196 (0%)1/196 (0.5%)
Most frequent serious events
Most frequent serious events
EventHydrochlorothiazide 50mg TabletPlacebo Tablet
Hospital AdmissionGastrointestinal disorders1/1960/196
Most frequent other events
Most frequent other events
EventHydrochlorothiazide 50mg TabletPlacebo Tablet
Patient diagnosed with Pyelonephritis and urosepsisRenal and urinary disorders1/1960/196
Allergic ReactionImmune system disorders0/1961/196

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Hydrochlorothiazide 50mg TabletPlacebo TabletTotal
<=18 years000
Between 18 and 65 years201199400
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Hydrochlorothiazide 50mg TabletPlacebo TabletTotal
Female201199400
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Hydrochlorothiazide 50mg TabletPlacebo TabletTotal
American Indian or Alaska Native101
Asian134
Native Hawaiian or Other Pacific Islander101
Black or African American302151
White168175343
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Hydrochlorothiazide 50mg TabletPlacebo TabletTotal
United States201199400
08

Study locations

2 sites
  • St. David's North Austin Medical Center
    Austin, Texas 78758, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Apr 2025, 89 months.

Results were first posted in Jun 2026, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Oct 2, 2017
StartActual
Nov 21, 2017
Primary completionActual
Apr 22, 2025
CompletionActual
Apr 22, 2025
Results first posted
Jun 24, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03298802
Responsible party
Sponsor
First posted
Oct 2, 2017
Start date
Nov 21, 2017
Primary completion
Apr 22, 2025
Completion
Apr 22, 2025
Results posted
Jun 24, 2026
Last update
Jul 14, 2026

Study contacts

Benjamin Bush, M.D.
principal investigator · UTMB

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Hydrochlorothiazide

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