Acute Labetalol Use in Preeclampsia (ALERT)

• ClinicalTrials.gov Identifier: NCT03872336
• Recruitment Status: Recruiting
• First Posted: March 13, 2019
• Last Update Posted: March 13, 2019
• Sponsor: Albany Medical College
• Information provided by (Responsible Party): Albany Medical College

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preeclampsia With Severe Features	Drug: Experimental labetalol dose; Other: Current standard of care	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The principle investigator and outcomes assessor are masked to group assignment.
• Primary Purpose: Treatment
• Official Title: Acute Labetalol Use in Preeclampsia Randomized Trial
• Actual Study Start Date: February 18, 2019
• Estimated Primary Completion Date: March 1, 2021
• Estimated Study Completion Date: July 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Time to blood pressure control [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Asha Rijhsinghani; 518.262.4942; rijhsia@amc.edu

Contact: Yiwen Cui; 832.788.8154; cuiy@amc.edu

Locations

United States, New York

Albany Medical Center Obstetrics and Gynecology; Recruiting

Albany, New York, United States, 12208

Contact: OBGYN Research Director, MD 518-262-4942 obgynresearch@amc.edu

Sponsors and Collaborators

Albany Medical College

More Information

Publications of Results:

Committee on Obstetric Practice. Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-5. doi: 10.1097/01.AOG.0000460762.59152.d7.

• Responsible Party: Albany Medical College
• ClinicalTrials.gov Identifier: NCT03872336
• Other Study ID Numbers: 5254
• First Posted: March 13, 2019
• Last Update Posted: March 13, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Albany Medical College:

Hypertension; Labetalol; Obesity

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Labetalol; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antihypertensive Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists