NCT03872336|TerminatedPhase 4DMCFDA Drug
Study Stopped
Slow enrollment
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Slow enrollment
ALERT
Sponsor study identifier
interventional
15
1 country
1
Study Start
February 18, 2019
Actual (reported)Primary Completion
July 20, 2020
Actual (reported)Study Completion
July 20, 2020
Actual (reported)The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's body-mass index, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 20, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 18, 2019
Actual (reported)March 11, 2019
Actual (reported)March 13, 2019
Actual (reported)July 20, 2020
Actual (reported)July 20, 2020
Actual (reported)Time to blood pressure control
The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.
4 hours after last labetalol dosing
Differences in racial response
4 hours after last labetalol dosing
Maternal adverse events
within 3 months of delivery
Neonatal adverse events
within 28 days of delivery
Subjects receive 40mg, 60mg 80mg in succession after each severe BP
Subjects receive 20mg, 40mg 80mg in succession after each severe BP
Subjects who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the experimental dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.
Albany Medical Center Obstetrics and Gynecology
Albany, New York, 12208, United States
Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-525. doi: 10.1097/01.AOG.0000460762.59152.d7.
15 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2019
First Posted
March 13, 2019
Study Start
February 18, 2019
Actual (reported)Postpartum Management of Gestational Hypertensive Disorders Using Furosemide
Subjects who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the standard dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.
Contact the study team to confirm eligibility.
Primary Completion
July 20, 2020
Actual (reported)Study Completion
July 20, 2020
Actual (reported)Last Updated
July 22, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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