Prevention of Severe Postpartum Hypertension

Indiana University

Status and phase: Withdrawn; Phase 2

Conditions: Hypertension

Treatments: Drug: Furosemide; Drug: Placebo #2; Drug: Potassium chloride; Drug: Placebo #1

Study type: Interventional

Funder types: Other

Identifiers

NCT02450773

201501157

Details and patient eligibility

About

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.

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Furosemide/Potassium chloride

Experimental group

Description:

40 mg furosemide; 20 meq potassium chloride

Treatment:

Drug: Potassium chloride

Drug: Furosemide

Placebo

Placebo Comparator group

Description:

Placebo #1, Placebo #2

Treatment:

Drug: Placebo #1

Drug: Placebo #2