Furosemide vs Placebo in Severe Preeclampsia Postpartum

Furosemide Oral Versus Placebo for Reduction of Hospital Length of Stay in Postpartum Women With Severe Preeclampsia: A Double-Blind, Randomized Controlled Trial

This randomized, double-blind, placebo-controlled trial evaluates whether oral furosemide 40 mg, initiated 12 hours postpartum, reduces hospital length of stay compared to placebo (folic acid 5 mg) in postpartum women with severe preeclampsia. Secondary outcomes include need for rescue antihypertensive medications, weight reduction, and metabolic safety (hypokalemia, renal function). A total of 186 participants (93 per arm) will be enrolled across two hospitals in Honduras.

Background: Preeclampsia is a leading cause of maternal morbidity worldwide. Postpartum management focuses on blood pressure control and resolution of endothelial dysfunction. Loop diuretics like furosemide may accelerate normalization of intravascular volume and blood pressure, potentially reducing hospital stay.

Hypothesis: Furosemide 40 mg oral once daily reduces total postpartum hospital hours compared to placebo.

Study Design: Phase 2, randomized, double-blind, placebo-controlled, parallel-group trial.

Setting: Hospital Materno Infantil and Instituto Hondureño de Seguridad Social, Honduras.

Interventions:

Experimental: Furosemide 40 mg oral every 24 hours, starting at 12 hours postpartum, continued until hospital discharge.

Placebo: Folic acid 5 mg oral (identical appearance, packaging, and administration schedule).

Blinding: Double-blind. Only an independent pharmacist knows group assignment. Blinding is broken only for life-threatening adverse events.

Follow-up: Entirely inpatient, from enrollment (12 hours postpartum) until hospital discharge (estimated 3-7 days).

Inclusion Criteria:

• Signed informed consent (assent for minors 14-17 years with parental/guardian consent)
• Confirmed severe preeclampsia (BP ≥160/110 mmHg, or lower BP with thrombocytopenia, hepatic dysfunction, renal insufficiency, pulmonary edema, or cerebral/visual symptoms)
• Postpartum (12-24 hours after delivery, vaginal or cesarean)
• Hemodynamically stable (no vasopressors for ≥6 hours)
• Preserved diuresis (>30 mL/hour for ≥6 hours)
• Serum creatinine <0.8 mg/dL

Exclusion Criteria:

• Current or chronic diuretic use (before or during pregnancy)
• Known allergy to sulfonamides or furosemide
• Active febrile illness
• Known chronic kidney disease (eGFR <60 mL/min/1.73m²)
• Participation in another interventional trial
• Pregnancy (current - not applicable postpartum, but excludes undiagnosed concurrent pregnancy)