Severe PreeclampsiaPhase 2FUROPENCT07648251
Furosemide vs Placebo in Severe Preeclampsia Postpartum
A Phase 2 study testing Furosemide and Folic Acid 5 MG in people with Severe Preeclampsia, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 49 years, women only
- Conditions the study is for
- Severe Preeclampsia
- What is being tested?
- Furosemide and Folic Acid 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteHonduras
- Study dates
- 2 Nov 2026to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
Ricardo A. Gurierrez Ramirez, MD, MSc., 97546940, ricardo.gutierrez@unah.edu.hn
Francisco J. Salgado Turcios, MD
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Severe Preeclampsia
- Being tested
- Furosemide, Folic Acid 5 MG
- Keywords
- Preeclampsia, Furosemide, Postpartum, Hypertension, Length of Stay
- Medical subject headings
- Pre-Eclampsia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
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 MGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Experimental | Every 24 hours starting at 12 hours postpartum until discharge Receives: Drug: Furosemide |
| Placebo | Placebo comparator | Folic acid, 5 mg per day Every 24 hours starting at 12 hours postpartum until discharge Receives: Drug: Folic Acid 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first study dose (12 hours postpartum) up to hospital discharge, approximately 3 to 14 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At hospital discharge, approximately 3 to 14 days after first study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind (participant, investigator, outcomes assessor)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648251
- Sponsor's protocol ID
- PGO-UNAH-49-10-2026
- Acronym
- FUROPE
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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.
PubMed 39870324
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide Oral Versus Placebo for Reduction of Hospital Length of Stay in Postpartum Women With Severe Preeclampsia: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07648251
- Acronym / sponsor ID
- FUROPE / PGO-UNAH-49-10-2026
- Conditions
- Severe Preeclampsia
- Keywords
- Preeclampsia, Furosemide, Postpartum, Hypertension, Length of Stay
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind (participant, investigator, outcomes assessor)
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Experimental | Drug: FurosemideEvery 24 hours starting at 12 hours postpartum until discharge |
| Placebo | Placebo comparator | Drug: Folic Acid 5 MGFolic acid, 5 mg per day Every 24 hours starting at 12 hours postpartum until discharge |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideFurosemide 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. | Drug | Furosemide |
| Folic Acid 5 MGFolic 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. | Drug | Placebo |
Primary outcome
Hospital Length of Stay (Hours)
Time frame: From first study dose (12 hours postpartum) up to hospital discharge, approximately 3 to 14 days
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.
6 secondary outcomes
Proportion Requiring Rescue Antihypertensive Medication
Time frame: From first study dose (12 hours postpartum) until hospital discharge, approximately 3 to 14 days
Weight Reduction (Delta Weight in kg)
Time frame: Baseline (12 hours postpartum) and at hospital discharge (approximately 3 to 14 days later)
Incidence of Hypokalemia
Time frame: At 48 hours after first study dose or at hospital discharge (approximately 3 to 14 days)
Renal Function Deterioration
Time frame: Baseline (12 hours postpartum) and at 48 hours or hospital discharge (approximately 3 to 14 days)
Spontaneously Reported Adverse Events
Time frame: From first study dose (12 hours postpartum) until hospital discharge, daily assessment, approximately 3 to 14 days
Antihypertensive-Free Discharge
Time frame: At hospital discharge, approximately 3 to 14 days after first study dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 39870324Cursino 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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furosemide and Folic Acid 5 MG in people with Severe Preeclampsia, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A. Gutierrez-Ramirez, MD, MSc (+50497546940, ricardo.gutierrez@unah.edu.hn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (Hours) (time frame: From first study dose (12 hours postpartum) up to hospital discharge, approximately 3 to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07648251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.