Acute Labetalol Use in Preeclampsia

NCT03872336 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 5254
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia With Severe Features

Keywords

Hypertension; Labetalol; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Experimental labetalol dose

EXPERIMENTAL

Subjects receive 40mg, 60mg 80mg in succession after each severe BP

Drug: Experimental labetalol dose

Current standard of care

ACTIVE COMPARATOR

Subjects receive 20mg, 40mg 80mg in succession after each severe BP

Other: Current standard of care

Interventions

Experimental labetalol dose DRUG

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.

Experimental labetalol dose

Current standard of care OTHER

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.

Current standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center Obstetrics and Gynecology

Albany, New York, 12208, United States

Location

Related Publications (1)

• 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.

  PMID: 25611642 RESULT

MeSH Terms

Conditions

Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principle investigator and outcomes assessor are masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: February 18, 2019
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)