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Furosemide vs. Placebo for Severe Antepartum Hypertension

NCT04615624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-04-18

Study results available
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Summary

Primary objective: To determine whether the addition of intravenous furosemide with usual antihypertensives is associated with a reduction in mean systolic blood pressure from baseline compared to treatment with placebo plus usual antihypertensives (intravenous labetalol, intravenous hydralazine, or oral immediate release nifedipine) for the management of severe antepartum hypertension.

Secondary objectives:

To determine whether the addition of intravenous furosemide with usual antihypertensives is associated with a reduction in mean diastolic blood pressure compared to treatment with placebo plus usual antihypertensives listed above.

Conditions

  • Pre-Eclampsia
  • Hypertension in Pregnancy
  • Pregnancy Complications
  • Hypertension, Pregnancy-Induced

Interventions

DRUG

Furosemide

Furosemide, a loop diuretic

OTHER

Placebo

Normal saline

Sponsors & Collaborators

  • Melanie Maykin, MD

    lead OTHER

Principal Investigators

  • Stacy Tsai, MD · Maternal-Fetal Medicine Faculty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2022-04-22
Completion
2022-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615624 on ClinicalTrials.gov