- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04343235
Postpartum Management of Gestational Hypertensive Disorders Using Furosemide
Postpartum Management of Gestational Hypertensive Disorders Using Furosemide: A Randomized Controlled Trial
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Literature Review
- There have been four documented studies investigating loop diuretics in the management of postpartum hypertensive disorders- Matthews et al2, Ascarelli et al3, Amorim et al4, and Veena et al. Of these studies, only Amorim and Veena were able to show statistical significance on any parameters. Amorim was able to show that there was an improvement of SBP, DBP and MAP, but the research was only presented as an abstract at a conference and not published, thereby making it impossible to draw any conclusions or practice guidelines. Veena demonstrated that by using furosemide and nifedipine in combination, the need for additional antihypertensive medication in severe pre-eclampsia in the postpartum period was reduced when compared to nifedipine alone.
- A systematic review5 of postpartum hypertensive disorder management suggested that there was insufficient data to recommend any single pharmacological intervention at this time in the management of gestational hypertensive disorders. The review emphasized the need for further studies to be conducted to help guide management of patients affected by gestational hypertensive disorders in the future.
Objectives
● Main Question
- Does the use of furosemide plus labetalol improve blood pressures in the postpartum period of patients with gestational hypertensive disorders versus labetalol alone?
Primary
■ Will there be a requirement to escalate antihypertensive therapy to control blood pressures
Secondary
- Improvement of gestational hypertensive disorders by measurement of systolic blood pressure, diastolic blood pressure and mean arterial pressure
- Shortened hospital stay in patients with hypertensive disorders
- Breastfeeding status at 1 week postpartum visit in mothers planning to breastfeed
- Readmission for postpartum hypertensive disorders
Significance to patient, institution, and profession
- As a referral center and being the region's leader, Miami Valley is very accustomed to accepting transfers of high acuity patients often times with hypertensive disorders being the root cause of the transport
- The majority of the OB staff population being served at Miami Valley Hospital is African American. According to Myatt6, the incidence of pre-eclampsia in the African American population is greater than double the Caucasian population (11% to 5%) thereby making this study very applicable to the patient population served at Miami Valley Hospital.
- With the construct of the study, costs abe kept low by utilizing already established resources and practices (blood pressure cuffs, nurses, routine one week blood pressure checks) while only adding on the unit cost of furosemide.
- If treatment with labetalol and furosemide is found to be useful, it would be not only a very inexpensive, cost effective way of improving patient outcomes and possibly decreasing lengths of stay stateside, but in improving global practice in places that are lacking in resources privy to first world countries.
Methods
The study would be designed as:
- A prospective randomized 1:1 controlled trial including postpartum women with gestational hypertension or preeclampsia
- Patients with chronic hypertension would be excluded from the study
- One arm receiving 200mg labetalol BID alone on PPD#1 or 24 hours after magnesium sulfate
- One arm receiving 200mg labetalol BID and a five day course of furosemide 20mg QD on PPD#1 or 24 hours after magnesium sulfate
Recording any occurrence when an increased amount of labetalol is needed to maintain blood pressures below 150 SBP and/or 100 DBP per ACOG recommendations.7
■ In the event of persistently elevated blood pressures, labetalol will be increased to 400mg TID and escalated to 600mg TID and finally 800mg TID as indicated
- Measurement of blood pressure every four hours after administration until patient discharge
- Measurement of urine output every 12 hours until discharge
- Compare average systolic, diastolic and mean arterial pressures between the two groups during admission and at one week postpartum
- Data will be collected using the OB Staff population at Miami Valley Hospital Main Campus.
- The research will be analyzed and interpreted by the research team conducting the study.
- Potential difficulties and limitations include compliance concerns of mandatory one week blood pressure follow up appointment.
- Using the Veena et al paper as a frame of reference, a sample size of 140 divided evenly across the two treatment arms would achieve statistical significance in determining the need to escalate anti-hypertensive therapy.
- The unit cost of one tablet of labetalol 200mg and furosemide 20mg is currently $0.32 and $1.23, respectively. 8,9
- The study would use already readily available automated blood pressure cuff machines on the postpartum wing.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ohio
-
Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Postpartum women delivering at Miami Valley Hospital
- Diagnosis of gestational hypertension or preeclampsia
- Able to provide written informed consent
Exclusion Criteria:
- Diagnosis of chronic hypertension
- Allergy to study medications
- Unable to understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: labetalol + furosemide
|
five day course of furosemide 20mg QD
Other Names:
200mg labetalol BID
Other Names:
|
Active Comparator: labetalol only
|
200mg labetalol BID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Dose for Antihypertensive Therapy
Time Frame: Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)
Time Frame: Average systolic blood pressure for Day 0, Day 1, and Day 2
|
average systolic blood pressure reading on Day 0, Day 1, and Day 2
|
Average systolic blood pressure for Day 0, Day 1, and Day 2
|
Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)
Time Frame: Average mean arterial pressure on Day 0, Day 1, and Day 2
|
average mean arterial pressure reading on Day 0, Day 1, and Day 2
|
Average mean arterial pressure on Day 0, Day 1, and Day 2
|
Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)
Time Frame: Average diastolic blood pressure on Day 0, Day 1, and Day 2
|
average diastolic blood pressure reading on Day 0, Day 1, and Day 2
|
Average diastolic blood pressure on Day 0, Day 1, and Day 2
|
Hospital Length of Stay
Time Frame: Number of days of hospital stay from randomization to discharge
|
days in hospital after delivery
|
Number of days of hospital stay from randomization to discharge
|
Breastfeeding Status
Time Frame: at 1 week postpartum visit
|
breastfeeding continuation after discharge
|
at 1 week postpartum visit
|
Hospital Readmission
Time Frame: up to 14 days after discharge
|
readmission for hypertension management
|
up to 14 days after discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheela Barhan, MD, Wright State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Pregnancy Complications
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Hypertension
- Hypertension, Pregnancy-Induced
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sympathomimetics
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
- Labetalol
Other Study ID Numbers
- 06784
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Hypertension, Pregnancy-Induced
-
Minia UniversityRecruitingPregnancy Induced HypertensionEgypt
-
Indonesia UniversityCompletedPregnancy Induced HypertensionIndonesia
-
Georges HatemCompletedDevelopment and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced HypertensionPregnancy Related | Hypertension in PregnancyLebanon
-
King's College Hospital NHS TrustBarts and the London School of Medicine and Dentistry; Fetal Medicine FoundationUnknownPre-Eclampsia | Hypertension in Pregnancy | Gestational Hypertension | Pregnancy Induced HypertensionUnited Kingdom
-
Columbia UniversityNot yet recruitingPostpartum Preeclampsia | Hypertensive Emergency | Postpartum Pregnancy-Induced Hypertension | Pregnancy-Induced Hypertension in PostpartumUnited States
-
Federal University of ParaíbaCompletedHypertension | Pregnancy-Induced Hypertension in Postpartum | Postpartum Pre-EclampsiaBrazil
-
Bournemouth UniversitySuspendedPregnancy-Induced HypertensionUnited Kingdom
-
University of CalgaryActive, not recruitingPregnancy Related | Pregnancy Induced Hypertension
-
UMC UtrechtUniversity of Ghana; Ghana Health ServicesUnknownPregnancy Induced HypertensionGhana
-
Ohio State UniversityCompletedHypertension | Preeclampsia | Pregnancy Induced HypertensionUnited States
Clinical Trials on furosemide
-
NYU Langone HealthWithdrawnPremature Birth | Premature InfantUnited States
-
Johns Hopkins UniversityscPharmaceuticals, Inc.Completed
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart FailureUnited States, Canada
-
Jan Kochanowski UniversityRecruiting
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedBronchopulmonary DysplasiaUnited States
-
Chiang Mai UniversityRecruiting
-
Stadtspital ZürichOspedale Regionale di LuganoRecruitingAcute Heart Failure | Diuretic ResistanceSwitzerland
-
Puerta de Hierro University HospitalInstituto de Salud Carlos III; Spanish Society of CardiologyCompleted