Postpartum Management of Gestational Hypertensive Disorders Using Furosemide

NCT04343235 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 06784
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

• The main purpose of this study is to learn if incorporating a loop diuretic such as furosemide along with labetalol in the routine management of postpartum gestational hypertensive disorders could lower the need for additional anti-hypertensive agents to control blood pressures, improve blood pressures (as measured by systolic blood pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital stays and decrease readmissions for patients with gestational hypertensive disorders.
• Based on a study by Veena et al1, there is reason to believe that the addition of furosemide to other anti-hypertensives may help decrease the need to add or increase the dose of medication to control blood pressures. There may be potential to shorten hospital stays and decrease readmissions, as well. Collecting data will be done using a prospective, randomized 1:1 controlled study assigning postpartum patients with a gestational hypertensive diagnosis to either labetalol alone or labetalol plus furosemide.
• The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus and would use patients who have consented to participate in the study with enrollees coming from the OB Staff population.

Conditions

Hypertension, Pregnancy-Induced

Keywords

pregnancy induced hypertension; preeclampsia; furosemide

Outcome Measures

Primary Outcomes (1)

• Change of Dose for Antihypertensive Therapy

  number of patients who require a change in the dose of labetalol to control BP

  Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)

Secondary Outcomes (6)

• Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)

  Average systolic blood pressure for Day 0, Day 1, and Day 2

• Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)

  Average mean arterial pressure on Day 0, Day 1, and Day 2

• Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)

  Average diastolic blood pressure on Day 0, Day 1, and Day 2

• Hospital Length of Stay

  Number of days of hospital stay from randomization to discharge

• Breastfeeding Status

  at 1 week postpartum visit

Study Arms (2)

labetalol + furosemide

EXPERIMENTAL

labetalol + furosemide

Drug: furosemide; Drug: labetalol

labetalol only

ACTIVE COMPARATOR

labetalol only

Drug: labetalol

Interventions

furosemide DRUG

five day course of furosemide 20mg QD

Also known as: lasix

labetalol + furosemide

labetalol DRUG

200mg labetalol BID

Also known as: trandate

labetalol + furosemide; labetalol only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum women delivering at Miami Valley Hospital
• Diagnosis of gestational hypertension or preeclampsia
• Able to provide written informed consent

You may not qualify if:

• Diagnosis of chronic hypertension
• Allergy to study medications
• Unable to understand English

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Related Publications (6)

• 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

• Matthews G, Gornall R, Saunders NJ. A randomised placebo controlled trial of loop diuretics in moderate/severe pre-eclampsia, following delivery. J Obstet Gynaecol. 1997 Jan;17(1):30-2. doi: 10.1080/01443619750114040.

  PMID: 15511760 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

• Cairns AE, Pealing L, Duffy JMN, Roberts N, Tucker KL, Leeson P, MacKillop LH, McManus RJ. Postpartum management of hypertensive disorders of pregnancy: a systematic review. BMJ Open. 2017 Nov 28;7(11):e018696. doi: 10.1136/bmjopen-2017-018696.

  PMID: 29187414 BACKGROUND

• Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Iams JD, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012 Jun;119(6):1234-42. doi: 10.1097/AOG.0b013e3182571669.

  PMID: 22617589 BACKGROUND

• Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

  PMID: 24150027 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Interventions

Furosemide; Labetalol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides

Results Point of Contact

• Title: Sheela Barhan, MD
• Organization: Wright State University

sheela.barhan@wright.edu

937-208-2850

Study Officials

• Sheela Barhan, MD

  Wright State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomized open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: April 13, 2020
• Study Start: May 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)