Phase 3
N=82
Lasix for the Prevention of De Novo Postpartum Hypertension
Postpartum Pregnancy-Induced Hypertension · Postpartum Preeclampsia · Hypertension, Pregnancy-Induced · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04752475 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Mean Arterial Blood Pressure (MAP) — 88.9; 86.8 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Furosemide (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Arterial Blood Pressure (MAP) |
88.9; 86.8 | — |
| SECONDARY Time to Discharge |
2.0; 2.0 | — |
| SECONDARY Rate of de Novo Postpartum Preeclampsia |
5; 3 | — |
| SECONDARY Percent of Recorded Blood Pressures That Are Elevated |
4; 0; 8; 5; 8; 5 | — |
| SECONDARY Rate of Magnesium Sulfate Administration |
2; 2 | — |
| SECONDARY Rate of Initiation of Antihypertensives |
4; 3 | — |
| SECONDARY Rate of Severe Maternal Morbidity |
0; 1 | — |
| SECONDARY Rate of Triage or Emergency Department (ED) Presentation/Readmission |
4; 2 | — |
| SECONDARY Breastfeeding Continuation Rate |
5; 5; 7; 5 | — |
Summary
Primary objective: To evaluate whether oral furosemide can help prevent de novo postpartum hypertension (new-onset high blood pressure after delivery) by reducing blood pressure after delivery in high-risk women.
Secondary objectives: To evaluate whether oral furosemide administered to high-risk women after delivery can reduce the frequency of postpartum hypertensive episodes, the need for antihypertensive therapy, the risk of postpartum preeclampsia, and the incidence of severe maternal morbidity.
Eligibility Criteria
Inclusion Criteria
- Postpartum women
- No antenatal diagnosis of hypertensive disorder of pregnancy at the time of admission for delivery, defined as existing chronic hypertension diagnosis or documented blood pressure of ≥140 systolic OR ≥90 diastolic on at least 2 occasions at least 4 hours apart prior to delivery admission who do not go on to get magnesium for seizure prophylaxis by the time of delivery
- At least 18 years of age
- English or Spanish speakers
- One or more high risk factors for development of de novo postpartum hypertension
Exclusion Criteria
- Non-English or Spanish speakers
- Women with a contraindication to diuretic therapy
- Women who have used diuretics in the two weeks prior to delivery
Data sourced from ClinicalTrials.gov (NCT04752475). 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.