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Lasix for the Prevention of De Novo Postpartum Hypertension

NCT ID: NCT04752475

Last Updated: 2024-12-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2022-05-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Pregnancy-Induced Hypertension Postpartum Preeclampsia Hypertension, Pregnancy-Induced Hypertension

Keywords

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De novo postpartum hypertension New-onset postpartum hypertension Lasix Furosemide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a randomized controlled clinical trial of 82 women with one or more high-risk factors for de novo postpartum hypertension, randomized to one of two arms: 20 mg PO Lasix (furosemide) daily for 5 days or identical-appearing daily placebo for 5 days.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Consenting women will be assigned to Lasix (furosemide) or placebo in a 1:1 ratio according to a randomization scheme achieved using a computer generated algorithm. Neither the participant nor the clinical care team will be aware of the allocation arm.

Study Groups

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Lasix (furosemide)

Furosemide 20 mg, oral, once daily for 5 days

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Furosemide 20 mg pill taken daily for 5 days

Placebo

Identical-appearing placebo, oral, once daily for 5 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Identical-appearing placebo pill taken daily for 5 days

Interventions

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Furosemide

Furosemide 20 mg pill taken daily for 5 days

Intervention Type DRUG

Placebo

Identical-appearing placebo pill taken daily for 5 days

Intervention Type OTHER

Other Intervention Names

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Lasix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Russell S. Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Clark SL, Belfort MA, Dildy GA, Herbst MA, Meyers JA, Hankins GD. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. Am J Obstet Gynecol. 2008 Jul;199(1):36.e1-5; discussion 91-2. e7-11. doi: 10.1016/j.ajog.2008.03.007. Epub 2008 May 2.

Reference Type BACKGROUND
PMID: 18455140 (View on PubMed)

ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.

Reference Type BACKGROUND
PMID: 30575675 (View on PubMed)

Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed postpartum preeclampsia and eclampsia: demographics, clinical course, and complications. Obstet Gynecol. 2011 Nov;118(5):1102-1107. doi: 10.1097/AOG.0b013e318231934c.

Reference Type BACKGROUND
PMID: 21979459 (View on PubMed)

Filetti LC, Imudia AN, Al-Safi Z, Hobson DT, Awonuga AO, Bahado-Singh RO. New onset delayed postpartum preeclampsia: different disorders? J Matern Fetal Neonatal Med. 2012 Jul;25(7):957-60. doi: 10.3109/14767058.2011.601365. Epub 2011 Aug 16.

Reference Type BACKGROUND
PMID: 21740315 (View on PubMed)

Matthys LA, Coppage KH, Lambers DS, Barton JR, Sibai BM. Delayed postpartum preeclampsia: an experience of 151 cases. Am J Obstet Gynecol. 2004 May;190(5):1464-6. doi: 10.1016/j.ajog.2004.02.037.

Reference Type BACKGROUND
PMID: 15167870 (View on PubMed)

Sibai BM. Diagnosis, prevention, and management of eclampsia. Obstet Gynecol. 2005 Feb;105(2):402-10. doi: 10.1097/01.AOG.0000152351.13671.99.

Reference Type BACKGROUND
PMID: 15684172 (View on PubMed)

Lubarsky SL, Barton JR, Friedman SA, Nasreddine S, Ramadan MK, Sibai BM. Late postpartum eclampsia revisited. Obstet Gynecol. 1994 Apr;83(4):502-5. doi: 10.1097/00006250-199404000-00003.

Reference Type BACKGROUND
PMID: 8134057 (View on PubMed)

Bigelow CA, Pereira GA, Warmsley A, Cohen J, Getrajdman C, Moshier E, Paris J, Bianco A, Factor SH, Stone J. Risk factors for new-onset late postpartum preeclampsia in women without a history of preeclampsia. Am J Obstet Gynecol. 2014 Apr;210(4):338.e1-338.e8. doi: 10.1016/j.ajog.2013.11.004. Epub 2013 Nov 7.

Reference Type BACKGROUND
PMID: 24211478 (View on PubMed)

Chames MC, Livingston JC, Ivester TS, Barton JR, Sibai BM. Late postpartum eclampsia: a preventable disease? Am J Obstet Gynecol. 2002 Jun;186(6):1174-7. doi: 10.1067/mob.2002.123824.

Reference Type BACKGROUND
PMID: 12066093 (View on PubMed)

Ascarelli MH, Johnson V, McCreary H, Cushman J, May WL, Martin JN Jr. Postpartum preeclampsia management with furosemide: a randomized clinical trial. Obstet Gynecol. 2005 Jan;105(1):29-33. doi: 10.1097/01.AOG.0000148270.53433.66.

Reference Type BACKGROUND
PMID: 15625138 (View on PubMed)

Veena P, Perivela L, Raghavan SS. Furosemide in postpartum management of severe preeclampsia: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):84-89. doi: 10.1080/10641955.2016.1239735. Epub 2016 Nov 11.

Reference Type BACKGROUND
PMID: 27835048 (View on PubMed)

Perdigao JL, Lewey J, Hirshberg A, et al. LB 4: Furosemide for Accelerated Recovery of Blood Pressure Postpartum: a randomized placebo controlled trial (FoR BP). American Journal of Obstetrics & Gynecology. 2020;222(1):S759-S760.

Reference Type BACKGROUND

Atterbury JL, Groome LJ, Hoff C. Blood pressure changes in normotensive women readmitted in the postpartum period with severe preeclampsia/eclampsia. J Matern Fetal Med. 1996 Jul-Aug;5(4):201-5. doi: 10.1002/(SICI)1520-6661(199607/08)5:43.0.CO;2-O.

Reference Type BACKGROUND
PMID: 8796794 (View on PubMed)

Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.

Reference Type BACKGROUND
PMID: 29703800 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AAAT2525

Identifier Type: -

Identifier Source: org_study_id