A Phase 2 interventional study of Furosemide and Folic Acid 5 MG in Severe Preeclampsia, sponsored by Universidad Nacional Autonoma de Honduras. Not yet recruiting at 1 site in Honduras. Open to female participants aged 14 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Universidad Nacional Autonoma de Honduras · Phase 2, Interventional, and Treatment
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).
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 186 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Universidad Nacional Autonoma de Honduras is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Every 24 hours starting at 12 hours postpartum until discharge
Drug: Furosemide
Folic acid, 5 mg per day Every 24 hours starting at 12 hours postpartum until discharge
Drug: Folic Acid 5 MG
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 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.
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
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
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)
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)
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)
Spontaneously Reported Adverse Events
Incidence of spontaneously reported adverse events potentially related to furosemide, including dizziness/orthostatic hypotension, muscle cramps, and palpitations. Participants are asked daily "Have you experienced any unusual symptoms since the last dose?" Responses are recorded regardless of suspected relationship to study drug. Severity is graded as mild (minimal or no treatment needed), moderate (some interference with daily activities), or severe (significant interference).
Time frame: From first study dose (12 hours postpartum) until hospital discharge, daily assessment, approximately 3 to 14 days
Antihypertensive-Free Discharge
Proportion of participants discharged from the hospital without requiring any maintenance antihypertensive medication. Maintenance antihypertensives are defined as scheduled oral medications (not rescue doses) intended to control blood pressure after discharge. Participants who require continued antihypertensive therapy at discharge (any dose, any agent) are considered not achieving antihypertensive-free discharge.
Time frame: At hospital discharge, approximately 3 to 14 days after first study dose
Plan to share: Yes — De-identified individual participant data (IPD) for all primary and secondary outcome measures will be shared publicly via Mendeley Data repository. The dataset will include: participant demographics, baseline clinical characteristics, primary outcome (hospital length of stay in hours), secondary outcomes (rescue medication requirement, weight change, laboratory values including potassium and creatinine, adverse events, discharge antihypertensive status), and protocol deviations. Data will be anonymized with no direct identifiers (name, medical record number, date of birth). Each participant will be identified by a unique study code only. Timeline: Data will be deposited within 12 months after primary results publication. The repository link will be included in the primary publication and in this ClinicalTrials.gov record when available. Supporting documents also available via Mendeley Data: Study protocol (v1.0), Statistical Analysis Plan (SAP), and blank informed consent form
Supporting information: Clinical study report
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.
Data sharing details ↗ · doi.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Furosemide
Universidad Nacional Autonoma de Honduras