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.
TERMINATED
PHASE3
453 participants
1-6 weeks postpartum
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
| 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
| 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 postpartumAny participants who had a visit to the hospital during the 1-6 weeks postpartum.
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 postpartumNumber of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window
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 postpartumDays that participants required to be in-house in the postpartum period
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 postpartumNumber of participants that receive one additional doses in the 1-6 weeks postpartum
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 postpartumNumber of participants that have a blood pressure greater than 150/90 in the 1-6 weeks postpartum window
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 postpartumNumber of participants with any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death.
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 PostpartumAllergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
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 postpartumNumber 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
| 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
Placebo Tablet
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place