Trial Outcomes & Findings for Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide (NCT NCT03298802)

NCT ID: NCT03298802

Last Updated: 2026-07-14

Results Overview

Any participants who had a visit to the hospital during the 1-6 weeks postpartum.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

453 participants

Primary outcome timeframe

1-6 weeks postpartum

Results posted on

2026-07-14

Participant Flow

A total of 453 individuals were initially recorded based on early recruitment and screening logs. After applying eligibility criteria and accounting for withdrawals prior to study start, 400 participants were enrolled and began the study.

Participant milestones

Participant milestones
Measure
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.
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
Overall Study
STARTED
201
199
Overall Study
COMPLETED
196
196
Overall Study
NOT COMPLETED
5
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hydrochlorothiazide 50mg Tablet
n=201 Participants
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.
Placebo Tablet
n=199 Participants
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
Total
n=400 Participants
Total of all reporting groups
Age, Categorical
Between 18 and 65 years
201 Participants
n=9 Participants
199 Participants
n=27 Participants
400 Participants
n=267 Participants
Age, Categorical
<=18 years
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Age, Categorical
>=65 years
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Sex: Female, Male
Female
201 Participants
n=9 Participants
199 Participants
n=27 Participants
400 Participants
n=267 Participants
Sex: Female, Male
Male
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants
Race (NIH/OMB)
Asian
1 Participants
n=9 Participants
3 Participants
n=27 Participants
4 Participants
n=267 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants
Race (NIH/OMB)
Black or African American
30 Participants
n=9 Participants
21 Participants
n=27 Participants
51 Participants
n=267 Participants
Race (NIH/OMB)
White
168 Participants
n=9 Participants
175 Participants
n=27 Participants
343 Participants
n=267 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Region of Enrollment
United States
201 participants
n=9 Participants
199 participants
n=27 Participants
400 participants
n=267 Participants

PRIMARY outcome

Timeframe: 1-6 weeks postpartum

Any participants who had a visit to the hospital during the 1-6 weeks postpartum.

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Number of Participants Required Re-Admission or Triage Visit
3 Participants
10 Participants

PRIMARY outcome

Timeframe: 1-6 weeks postpartum

Number of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Number of Participants That Need Additional Antihypertensive Therapy
6 Participants
6 Participants

SECONDARY outcome

Timeframe: 1-6 weeks postpartum

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

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Length of Hospital Stay
2.25 days
Standard Deviation 0.93
2.18 days
Standard Deviation 0.57

SECONDARY outcome

Timeframe: 1-6 weeks postpartum

Number of participants that receive one additional doses in the 1-6 weeks postpartum

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Total Additional Doses of Anti-hypertensive Therapy
6 Participants
6 Participants

SECONDARY outcome

Timeframe: 1-6 weeks postpartum

Number of participants that have a blood pressure greater than 150/90 in the 1-6 weeks postpartum window

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Elevation of Blood Pressure >150/90
21 Participants
15 Participants

SECONDARY outcome

Timeframe: 1-6 weeks postpartum

Number of participants with any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death.

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Severe Composite Maternal Morbidity
Maternal Death
0 Participants
0 Participants
Severe Composite Maternal Morbidity
Pulmonary edema
0 Participants
0 Participants
Severe Composite Maternal Morbidity
Renal failure
0 Participants
0 Participants
Severe Composite Maternal Morbidity
Stroke
0 Participants
0 Participants
Severe Composite Maternal Morbidity
HELLP syndrome
0 Participants
0 Participants
Severe Composite Maternal Morbidity
Eclampsia
0 Participants
0 Participants
Severe Composite Maternal Morbidity
ICU admission
0 Participants
0 Participants
Severe Composite Maternal Morbidity
Cardiomyopathy
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 1-6 weeks Postpartum

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

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Adverse Events
Angioedema
0 Participants
0 Participants
Adverse Events
Skin Rashes Including Stevens Johnson
0 Participants
0 Participants
Adverse Events
Anaphylaxis
0 Participants
0 Participants
Adverse Events
Skin Rashes Including Toxic Epidermal Necrolysis
0 Participants
0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-6 weeks postpartum

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.

Outcome measures

Outcome measures
Measure
Hydrochlorothiazide 50mg Tablet
n=196 Participants
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.
Placebo Tablet
n=196 Participants
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
Use of Resources
Clinic or Emergency room visit
0 Participants
0 Participants
Use of Resources
Need for Imaging
0 Participants
0 Participants
Use of Resources
Need for other Invasive Procedures
0 Participants
0 Participants
Use of Resources
Additional Hospital Stay
1 Participants
0 Participants

Adverse Events

Hydrochlorothiazide 50mg Tablet

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Placebo Tablet

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Hydrochlorothiazide 50mg Tablet
n=196 participants at risk
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.
Placebo Tablet
n=196 participants at risk
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
Gastrointestinal disorders
Hospital Admission
0.51%
1/196 • 1-6 weeks postpartum
0.00%
0/196 • 1-6 weeks postpartum

Other adverse events

Other adverse events
Measure
Hydrochlorothiazide 50mg Tablet
n=196 participants at risk
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.
Placebo Tablet
n=196 participants at risk
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
Renal and urinary disorders
Patient diagnosed with Pyelonephritis and urosepsis
0.51%
1/196 • 1-6 weeks postpartum
0.00%
0/196 • 1-6 weeks postpartum
Immune system disorders
Allergic Reaction
0.00%
0/196 • 1-6 weeks postpartum
0.51%
1/196 • 1-6 weeks postpartum

Additional Information

Corey Clifford, DO

UTMB

Phone: 409-772-0312

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place