Furosemide vs Placebo in Severe Preeclampsia Postpartum

NCT07648251 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PGO-UNAH-49-10-2026
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Preeclampsia

Keywords

Preeclampsia; Furosemide; Postpartum; Hypertension; Length of Stay

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay (Hours)

  Total hours from first study dose (administered at 12 hours postpartum) to hospital discharge. Discharge is defined as achievement and maintenance of blood pressure \<140/90 mmHg for at least 24 consecutive hours without need for rescue antihypertensive medication. Rescue medication is defined as any extra dose of labetalol or hydralazine administered for hypertensive crisis (blood pressure \>160/110 mmHg). Time is measured in hours from the moment of first dose (hour 0) until the moment discharge orders are written. If a patient requires rescue medication, the clock does not reset; discharge criteria must still be met for 24 hours without rescue.

  From first study dose (12 hours postpartum) up to hospital discharge, approximately 3 to 14 days

Secondary Outcomes (6)

• Proportion Requiring Rescue Antihypertensive Medication

  From first study dose (12 hours postpartum) until hospital discharge, approximately 3 to 14 days

• Weight Reduction (Delta Weight in kg)

  Baseline (12 hours postpartum) and at hospital discharge (approximately 3 to 14 days later)

• Incidence of Hypokalemia

  At 48 hours after first study dose or at hospital discharge (approximately 3 to 14 days)

• Renal Function Deterioration

  Baseline (12 hours postpartum) and at 48 hours or hospital discharge (approximately 3 to 14 days)

• Spontaneously Reported Adverse Events

  From first study dose (12 hours postpartum) until hospital discharge, daily assessment, approximately 3 to 14 days

Study Arms (2)

Furosemide

EXPERIMENTAL

Every 24 hours starting at 12 hours postpartum until discharge

Drug: Furosemide

Placebo

PLACEBO COMPARATOR

Folic acid, 5 mg per day Every 24 hours starting at 12 hours postpartum until discharge

Drug: Folic Acid 5 MG

Interventions

Furosemide DRUG

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 medication: labetalol or hydralazine for BP \>160/110 mmHg, deferred ≥2 hours after study drug when possible. Placebo comparator: folic acid 5 mg orally every 24 hours, identical appearance, packaging, and schedule. What distinguishes this intervention: first postpartum diuretic trial in severe preeclampsia with hospital length of stay as primary endpoint in a low-middle income country setting.

Furosemide

Folic Acid 5 MG DRUG

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.

Placebo

Eligibility Criteria

• Age: 14 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Interventions

Furosemide; Folic Acid

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Ricardo A. Gutierrez-Ramirez, MD, MSc

CONTACT

+50497546940; ricardo.gutierrez@unah.edu.hn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1. Participants - Patients receive identical opaque white bottles labeled only with "Estudio FURO-PE, Paciente #XXX" and have no knowledge of whether the contents are furosemide 40 mg or placebo (folic acid 5 mg). 2. Investigators (Principal Investigators and Sub-investigators) - All clinical staff responsible for enrollment, outcome assessment, and discharge decisions are unaware of group assignment. 3. Outcome assessors - The same research team members who evaluate blood pressure, laboratory results, and discharge criteria are masked. 4. Statistician - The data analyst will receive a dataset with group codes (A/B) and will not know which code corresponds to furosemide or placebo until final database lock. Only one independent, unblinded person (a designated pharmacist not involved in patient care or outcome assessment) knows the allocation. This person prepares and labels all bottles but does not interact with participants or investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Double-blind (participant, investigator, outcomes assessor)

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Available starting 12 months after primary results publication. Available for 5 years thereafter.
• Access Criteria: No registration or authorization required for download. Data will be under a CC BY-NC 4.0 license (Creative Commons Attribution-NonCommercial 4.0 International), allowing other researchers to use, share, and adapt the data for non-commercial purposes with proper attribution.

Locations

HO (1)