Acute Labetalol Use in Preeclampsia

NCT ID: NCT03872336

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2020-07-20

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.

Conditions

Preeclampsia With Severe Features

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental labetalol dose

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

Group Type: EXPERIMENTAL

Experimental labetalol dose

Intervention Type: 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.

Current standard of care

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

Group Type: ACTIVE_COMPARATOR

Current standard of care

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Albany Medical Center Obstetrics and Gynecology

Albany, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25611642 (View on PubMed)

Other Identifiers

5254

Identifier Type: -

Identifier Source: org_study_id