Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

The University of Texas System (UT)

Status and phase: Enrolling; Phase 3

Conditions: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Superimposed Pre-Eclampsia; Gestational Hypertension; Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia

Treatments: Drug: Placebo Tablet; Drug: Hydrochlorothiazide 50mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03298802

16-0280

Details and patient eligibility

About

Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.

Full 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.

Enrollment: 612 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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 (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.)

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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612 participants in 2 patient groups, including a placebo group

Hydrochlorothiazide 50mg Tablet

Active Comparator group

Description:

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.

Treatment:

Drug: Hydrochlorothiazide 50mg Tablet

Placebo Tablet

Placebo Comparator group

Description:

Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum

Treatment:

Drug: Placebo Tablet