Furosemide vs. Placebo for Severe Antepartum Hypertension

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melanie Maykin, MD
• Treatments: Furosemide

Criteria

Inclusion Criteria:

• Subjects 18 years of age or older

• Subjects with intrauterine pregnancy at or beyond 20 weeks of gestation

• Subjects with a diagnosis of hypertensive disorder in pregnancy

• Subjects with persistent (on repeat BP check 15 min apart) severe range blood pressure recordings (systolic BP greater than or equal to 160 or diastolic greater than or equal to BP 110) with wide pulse pressure (>60 mmHg)

• Subject able to provide informed consent

Exclusion Criteria:

• Subjects less than 18 years of age

• Subjects with intrauterine pregnancy less than 20 weeks of gestation

• Subjects with known fetal anomaly

• Subjects with hypokalemia (K <3.0 milliequivalent per liter) on admission

• Subjects with anuria (<50 milliliters urine in 24 hours) or renal failure

• Subjects previously taking diuretics or potassium supplements for any reason

• Subjects with a known allergy/adverse reaction to furosemide

• Subjects who are unable to understand and/or sign the informed consent