Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

Study Overview
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Brief Summary
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Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.

Detailed Description
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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.

Official Title
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Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial

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

Intervention / Treatment
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* Drug: Hydrochlorothiazide 50mg Tablet
* Drug: Placebo Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind randomized placebo controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrochlorothiazide 50mg Tablet<br>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<br>* 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.<br>* Other names: HydroDIURIL, Microzide, Esidrix, Oretic;|
| Placebo Comparator: Placebo Tablet<br>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<br>* 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<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of readmission and/or triage visits | Any visit in the hospital | 1-6 weeks postpartum | 
| Need for additional antihypertensive therapy | Requiring additional antihypertensive agents in the postpartum period | 1-6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Days that patient required to be in-house in the postpartum period | 1-6 weeks postpartum | 
| Total Additional doses of anti-hypertensive therapy | Addition of total doses that patient received in the postpartum period | 1-6 weeks postpartum | 
| Elevation of blood pressure >150/90 | Hypertension definition in the postpartum period | 1-6 weeks postpartum | 
| Severe composite maternal morbidity | o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death | 1-6 weeks postpartum | 
| Use of resources | hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures. | 1-6 weeks postpartum | 
| Adverse Events | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis) | 1-6 weeks Postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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readmission, triage visit for pregnancy related hypertension, hydrochlorothiazide