Health Trials

Furosemide vs Placebo in Severe Preeclampsia Postpartum

ConditionSevere Preeclampsia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age14-49
SponsorUniversidad Nacional Autonoma de Honduras

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: FurosemideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Proportion Requiring Rescue Antihypertensive Medication

Percentage of participants in each arm who require at least one dose of rescue antihypertensive medication (labetalol or hydralazine) during hospitalization. Rescue medication is indicated for hypertensive crisis defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>110 mmHg at any time after study drug administration. The proportion is calculated as number of participants receiving any rescue dose divided by total participants in the arm.

Time frame
From first study dose (12 hours postpartum) until hospital discharge, approximately 3 to 14 days
2

Weight Reduction (Delta Weight in kg)

Absolute difference between baseline weight (measured at 12 hours postpartum, immediately before first study dose) and weight at hospital discharge (measured on the morning of discharge day). Weight is measured in kilograms using the same calibrated scale for each participant. Delta weight is calculated as baseline weight minus discharge weight. A positive value indicates weight loss.

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

Incidence of Hypokalemia

Proportion of participants in each arm developing hypokalemia, defined as serum potassium \<3.0 mEq/L. Blood sample is drawn at 48 hours after first study dose or at hospital discharge (whichever occurs first). Hypokalemia is considered an adverse event of special interest given furosemide's mechanism of action as a loop diuretic. Severe hypokalemia (\<2.5 mEq/L) triggers unblinding and protocol-defined management.

Time frame
At 48 hours after first study dose or at hospital discharge (approximately 3 to 14 days)
4

Renal Function Deterioration

Change in serum creatinine from baseline to follow-up measurement. Baseline creatinine is measured at enrollment (12 hours postpartum, before first dose). Follow-up creatinine is measured at 48 hours after first dose or at hospital discharge (whichever occurs first). Renal deterioration is defined as an increase in serum creatinine of ≥0.3 mg/dL from baseline or a percentage increase of ≥50%. Mean change (absolute and percentage) is compared between groups.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Nacional Autonoma de Honduras

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: