Acute Labetalol Use in Preeclampsia

Preeclampsia With Severe Features Clinical Trial

— ALERT  

Official title:

Acute Labetalol Use in Preeclampsia Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03872336
• Other study ID #: 5254
• Status: Terminated
• Phase: Phase 4
• Start date: February 18, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: July 2020
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia With Severe Features

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Albany Medical Center Obstetrics and Gynecology	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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