Lasix for the Prevention of De Novo Postpartum Hypertension (LAPP)

December 11, 2024 updated by: Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lasix (furosemide)
Furosemide 20 mg, oral, once daily for 5 days
Drug: Furosemide
Furosemide 20 mg pill taken daily for 5 days
Other Names:
  • Lasix
Placebo Comparator: Placebo
Identical-appearing placebo, oral, once daily for 5 days
Other: Placebo
Identical-appearing placebo pill taken daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours prior to discharge through discharge, up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discharge
Time Frame: Randomization through discharge, up to 7 days
Time until discharge from the hospital
Randomization through discharge, up to 7 days
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.
Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum
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).
Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum
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.
Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum
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.
Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum
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.
Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum
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.
2 weeks postpartum, 6 weeks postpartum
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.
2 weeks postpartum, 6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Russell S. Miller, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Actual)

April 18, 2022

Study Completion (Actual)

May 28, 2022

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT2525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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