Acute Labetalol Use in Preeclampsia

Phase 4

Terminated

• Conditions: Preeclampsia With Severe Features
• Interventions: Drug: Experimental labetalol dose; Other: Current standard of care

• Registration Number: NCT03872336
• Lead Sponsor: Albany Medical College

Brief Summary

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.

Detailed Description

The investigators seek to asses the effect of obesity (BMI\>30) on severe hypertension control in patients with preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015.

Study Timeline

• Study Start: 2019-02-18
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Status Verified: 2020-07
• Primary Completion: 2020-07-20
• Study Completion: 2020-07-20
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• BMI ≥ 30
• Age ≥ 18 years
• Gestational age ≥ 24 weeks
• Singleton gestation
• One sustained severe range blood pressure at Albany Medical Center

Exclusion Criteria

• Known allergic reaction to labetlol
• Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
• Obstructive airway disease
• Bradycardia < 70 beats/min
• Heart block > 1st degree or history of heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental labetalol dose	Experimental labetalol dose	Subjects receive 40mg, 60mg 80mg in succession after each severe BP
Current standard of care	Current standard of care	Subjects receive 20mg, 40mg 80mg in succession after each severe BP

Primary Outcome Measures

Name	Time	Method
Time to blood pressure control	4 hours after last labetalol dosing	The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.

Secondary Outcome Measures

Name	Time	Method
Maternal adverse events	within 3 months of delivery	Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Neonatal adverse events	within 28 days of delivery	complications experienced by the neonate including PGAR score \< 5, need for respiratory support, blood glucose, death
Differences in racial response	4 hours after last labetalol dosing	The difference in time for blood pressure control amongst racial groups

Trial Locations

Locations (1)

Albany Medical Center Obstetrics and Gynecology; 🇺🇸 Albany, New York, United States