Prevention of Severe Postpartum Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension.

Official Title
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Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Furosemide
* Drug: Potassium chloride
* Drug: Placebo #1
* Drug: Placebo #2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women > 18 years of age or emancipated minors Women undergoing vaginal or cesarean delivery at > 23 weeks gestation with: Antepartum diagnosis of gestational hypertension Antepartum diagnosis of preeclampsia Antepartum diagnosis of preeclampsia with severe features Mild hypertension (<150/100) in first 24 hours following delivery Exclusion Criteria: Chronic hypertension Allergy to furosemide Pre-existing hypokalemia (serum K < 3.0 meq/L) Chronic kidney disease Serum Cr > 1.1 Inability to obtain informed consent Pre-existing diuretic use Oliguria
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide/Potassium chloride<br>40 mg furosemide; 20 meq potassium chloride | Drug: Furosemide<br>* 40 mg furosemide on postpartum day 1-6<br>* Other names: Lasix;Drug: Potassium chloride<br>* 20 meq potassium chloride on postpartum day 1-6<br>* Other names: KCl;|
| Placebo Comparator: Placebo<br>Placebo #1, Placebo #2 | Drug: Placebo #1<br>* Placebo (for furosemide)<br>Drug: Placebo #2<br>* Placebo (for KCl)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite maternal morbidity | Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension | 0-6 weeks following delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events associated with furosemide | Hypokalemia | 0-6 weeks following delivery | 
| Adverse events associated with furosemide | hyperglycemia | 0-6 weeks following delivery | 
| Adverse events associated with furosemide | oliguria | 0-6 weeks following delivery | 
| Adverse events associated with furosemide | hypotension | 0-6 weeks following delivery | 
| Adverse events associated with furosemide | elevated serum creatinine | 0-6 weeks following delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum, preeclampsia, gestational hypertension