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Completed

NCT Number: NCT04752475

Lasix for the Prevention of De Novo Postpartum Hypertension

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

Hypertensive disorders of pregnancy are one of the leading causes of maternal morbidity and mortality worldwide. The majority of clinical research has focused on pregnancy-related hypertension that develops in the antenatal period, while studies of the incidence, risk factors, and prevention of postpartum hypertension are limited. In particular, there is a paucity of data about the clinical entity known as de novo postpartum hypertension, in which women who are normotensive throughout pregnancy and delivery subsequently go on to develop high blood pressure in the immediate to late postpartum period. Of those with postpartum preeclampsia, 33-69% were normotensive antepartum.

Early identification and treatment of antepartum preeclampsia has been shown to decrease some severe maternal outcomes. Conversely, women with de novo postpartum hypertensive disorders remain among the highest risk for severe maternal morbidity due to decreased surveillance and lack of data regarding preventive therapies and interventions. Evidence from multiple randomized controlled trials have demonstrated a benefit in the use of oral loop-diuretics in decreasing postpartum systolic blood pressure, promoting faster normalization of blood pressure, and decreasing the need for antihypertensive therapy in women with an antenatal diagnosis of preeclampsia. Biological plausibility suggests that loop-diuretic therapy may similarly mitigate the normal physiologic mechanism that has been implicated in the pathogenesis of hypertensive complications after delivery in women at risk for de novo postpartum hypertension.

This study is a double-blind randomized placebo-controlled trial of 82 high-risk women to assess whether treatment with oral Lasix (furosemide) after delivery reduces blood pressure at the time of discharge. Women at high risk for de novo postpartum hypertension will be randomized to a five-day course of either 20 mg oral Lasix (furosemide) or placebo once daily initiated after delivery. Women will be monitored through their routine 2-week and 6-week postpartum visits, during which times hypertensive complications and adverse effects of therapy will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

Furosemide 20 mg pill taken daily for 5 days

Other names: Lasix

Placebo

Other

Identical-appearing placebo pill taken daily for 5 days

Primary outcomes

  1. Mean Arterial Blood Pressure (MAP)

    Time frame: 24 hours prior to discharge through discharge, up to 7 days

    Difference in MAP averaged over the 24 hours prior to discharge or the 24 hours prior to antihypertensive therapy initiation (whichever occurs first)

Secondary outcomes

  1. Time to Discharge

    Time frame: Randomization through discharge, up to 7 days

    Time until discharge from the hospital

  2. Rate of de Novo Postpartum Preeclampsia

    Time frame: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

    Number of participants who develop de novo postpartum hypertension. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

  3. Percent of Recorded Blood Pressures That Are Elevated

    Time frame: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

    Percent of recorded blood pressures that are elevated (>140 systolic OR >90 diastolic).

  4. Rate of Magnesium Sulfate Administration

    Time frame: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

    Number of participants who receive intravenous magnesium sulfate for seizure prophylaxis. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

  5. Rate of Initiation of Antihypertensives

    Time frame: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

    Number of participants receiving intravenous antihypertensive therapy and initiated on oral hypertensive therapy. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

  6. Rate of Severe Maternal Morbidity

    Time frame: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

    Number of participants experiencing severe maternal morbidity (e.g. seizure, stroke, Posterior reversible encephalopathy syndrome (PRES), death, etc.) This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

  7. Rate of Triage or Emergency Department (ED) Presentation/Readmission

    Time frame: 2 weeks postpartum, 6 weeks postpartum

    Number of participants who experienced triage or ED presentation/readmission for hypertensive-related complaints. This outcome was assessed at 2 weeks postpartum and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

  8. Breastfeeding Continuation Rate

    Time frame: 2 weeks postpartum, 6 weeks postpartum

    Number of participants continuing to breastfeed of those who initiated breastfeeding after delivery. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 2 weeks and 6 weeks postpartum.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Lasix for the Prevention of De Novo Postpartum Hypertension: A Randomized Controlled Trial (LAPP Trial)

Acronym: LAPP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2021
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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