Phase 3
Completed N=65
Furosemide vs. Placebo for Severe Antepartum Hypertension
Pre-eclampsia · Hypertension in Pregnancy · pregnancy complications · Hypertension, Pregnancy-Induced
Source: ClinicalTrials.gov NCT04615624 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Mean Systolic Blood Pressure During Hour After Study Drug — 147; 152 mmHg
◆ Published Evidence
Emerging
8citations · ~4 / year
Furosemide to lower antenatal severe hypertension: a randomized placebo-controlled trial.
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.
Linked Publications
-
Furosemide to lower antenatal severe hypertension: a randomized placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Systolic Blood Pressure During Hour After Study Drug |
147; 152 | — |
| SECONDARY Mean Diastolic Blood Pressure During Hour After Study Drug |
88; 87 | — |
| SECONDARY Change From Qualifying Systolic Blood Pressure |
-26; -24 | — |
| SECONDARY Change From Qualifying Diastolic Blood Pressure |
-12; -11 | — |
| SECONDARY Pulse Pressure at 2 Hours After Study Drug. |
55; 67 | — |
| SECONDARY Systolic Blood Pressure at 2 Hours After Study Drug |
139; 154 | — |
| SECONDARY Diastolic Blood Pressure at 2 Hours After Study Drug |
84; 87 | — |
Eligibility 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
- Subjects who are in active labor defined as 6 centimeters of cervical dilation or more
- Subjects who have an epidural (neuraxial anesthesia) in place
Data sourced from ClinicalTrials.gov (NCT04615624) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.