Furosemide vs Placebo in Severe Preeclampsia Postpartum

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат Furosemide
  Furosemide 40 mg tablet, oral, once daily. First dose administered exactly 12 hours postpartum (vaginal or cesarean). Continued every 24 hours until hospital discharge, defined as blood pressure \<140/90 mmHg for ≥24 hours without rescue antihypertensives. Population: severe preeclampsia (BP ≥160/110 mmHg OR lower BP with thrombocytopenia, hepatic dysfunction, renal insufficiency, pulmonary edema, or cerebral/visual symptoms). Setting: postpartum wards in two public hospitals in Honduras. Rescue
• Препарат Folic Acid 5 MG
  Folic acid 5 mg oral once daily, starting at exactly 12 hours postpartum until hospital discharge (BP \<140/90 mmHg for ≥24 hours without rescue drugs). Population: severe preeclampsia. Setting: public hospitals, Honduras. Rescue: labetalor hydralazine for BP \>160/110 mmHg, deferred ≥2 hours post-dose. Active comparator: furosemide 40 mg oral, identical appearance and schedule. Folic acid has no antihypertensive or diuretic effects in postpartum women, serving as an appropriate placebo.

Первичные конечные точки

• Hospital Length of Stay (Hours) [Срок оценки: From first study dose (12 hours postpartum) up to hospital discharge, approximately 3 to 14 days]

Вторичные конечные точки (6)

• Proportion Requiring Rescue Antihypertensive Medication [Срок оценки: From first study dose (12 hours postpartum) until hospital discharge, approximately 3 to 14 days]
• Weight Reduction (Delta Weight in kg) [Срок оценки: Baseline (12 hours postpartum) and at hospital discharge (approximately 3 to 14 days later)]
• Incidence of Hypokalemia [Срок оценки: At 48 hours after first study dose or at hospital discharge (approximately 3 to 14 days)]
• Renal Function Deterioration [Срок оценки: Baseline (12 hours postpartum) and at 48 hours or hospital discharge (approximately 3 to 14 days)]
• Spontaneously Reported Adverse Events [Срок оценки: From first study dose (12 hours postpartum) until hospital discharge, daily assessment, approximately 3 to 14 days]
• Antihypertensive-Free Discharge [Срок оценки: At hospital discharge, approximately 3 to 14 days after first study dose]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Honduras · 1 центр

• Hospital Escuela — Tegucigalpa

Публикации

• Cursino T, Katz L, Coutinho I, de Souza ASR, Silva TV, Cunha ACCD, Amorim M. Postpartum furosemide for accelerating recovery in patients with preeclampsia: a randomized placebo-controlled trial. Am J Obstet Gynecol MFM. 2025 May;7(5):101614. doi: 10.1016/j.ajogmf.2025.101614. Epub 2025 Jan 25. PMID 39870324

Идентификаторы

NCT: NCT07648251 · PGO-UNAH-49-10-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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