Lasix for the Prevention of De Novo Postpartum Hypertension

NCT04752475 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AAAT2525
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

De novo postpartum hypertension; New-onset postpartum hypertension; Lasix; Furosemide

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Blood Pressure (MAP)

  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 Outcomes (8)

• Time to Discharge

  Randomization through discharge, up to 7 days

• Rate of de Novo Postpartum Preeclampsia

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

• Percent of Recorded Blood Pressures That Are Elevated

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

• Rate of Magnesium Sulfate Administration

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

• Rate of Initiation of Antihypertensives

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

Study Arms (2)

Lasix (furosemide)

EXPERIMENTAL

Furosemide 20 mg, oral, once daily for 5 days

Drug: Furosemide

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Furosemide DRUG

Furosemide 20 mg pill taken daily for 5 days

Also known as: Lasix

Lasix (furosemide)

Placebo OTHER

Identical-appearing placebo pill taken daily for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English or Spanish speakers
• Women with a contraindication to diuretic therapy
• Women who have used diuretics in the two weeks prior to delivery

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (14)

• 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.

  PMID: 18455140 BACKGROUND

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

  PMID: 30575675 BACKGROUND

• 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.

  PMID: 21979459 BACKGROUND

• 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.

  PMID: 21740315 BACKGROUND

• 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.

  PMID: 15167870 BACKGROUND

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

  PMID: 15684172 BACKGROUND

• 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.

  PMID: 8134057 BACKGROUND

• 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.

  PMID: 24211478 BACKGROUND

• 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.

  PMID: 12066093 BACKGROUND

• 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.

  PMID: 15625138 BACKGROUND

• 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.

  PMID: 27835048 BACKGROUND

• 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.

  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.

  PMID: 8796794 BACKGROUND

• 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.

  PMID: 29703800 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Russell Miller, MD
• Organization: Associate Professor of Prenatal Pediatrics at CUIMC

rsm20@cumc.columbia.edu

212-305-3151

Study Officials

• Russell S. Miller, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: October 20, 2021
• Primary Completion: April 18, 2022
• Study Completion: May 28, 2022
• Last Updated: December 13, 2024
• Results First Posted: May 11, 2023

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)