Acute Labetalol Use in Preeclampsia (ALERT)

Acute Labetalol Use in Preeclampsia Randomized Trial

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.

Study Overview

• Status: Terminated
• Conditions: Preeclampsia With Severe Features
• Intervention / Treatment: Drug: Experimental labetalol dose; Other: Current standard of care

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental labetalol dose; Subjects receive 40mg, 60mg 80mg in succession after each severe BP	Drug: Experimental labetalol dose; 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.
ACTIVE_COMPARATOR: Current standard of care; Subjects receive 20mg, 40mg 80mg in succession after each severe BP	Other: Current standard of care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Albany Medical College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2019
• Primary Completion (ACTUAL): July 20, 2020
• Study Completion (ACTUAL): July 20, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (ACTUAL): March 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Hypertension; Labetalol
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; 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; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Labetalol
• Other Study ID Numbers: 5254 (OHSU Knight Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No