Clinical trial

Postpartum Management of Gestational Hypertensive Disorders Using Furosemide: A Randomized Controlled Trial

Name
06784
Description
* 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.
Trial arms
Trial start
2020-05-01
Estimated PCD
2022-06-30
Trial end
2022-06-30
Status
Terminated
Phase
Early phase I
Treatment
furosemide
five day course of furosemide 20mg QD
Arms:
labetalol + furosemide
Other names:
lasix
labetalol
200mg labetalol BID
Arms:
labetalol + furosemide, labetalol only
Other names:
trandate
Size
13
Primary endpoint
Change of Dose for Antihypertensive Therapy
Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'randomized open label'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}
Updated at
2023-10-23

1 organization

1 product

1 drug

2 indications

Product
furosemide
Indication
Hypertension