Acute Control of Chronic Hypertension

Phase 4

Terminated

• Conditions: Chronic Hypertension in Obstetric Context; Preeclampsia With Severe Features
• Interventions: Drug: Experimental dosing of labetalol; Other: Standard dosing of labetalol

• Registration Number: NCT03877692
• Lead Sponsor: Albany Medical College

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 history of preexisting hypertension, 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 preexisting hypertension on the patient's response to treatment for severe hypertension in 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 Timeline

• Study Start: 2019-02-18
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Status Verified: 2020-07
• Primary Completion: 2020-07-20
• Study Completion: 2020-07-20
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Age ≥ 18 years
• Gestational age ≥ 24 weeks
• Singleton gestation
• Chronic hypertension as defined as two elevated blood pressures (SBP ≥ 140mmHg and/or DBP ≥ 90mmHg) at least 4 hours apart before 20 weeks gestation

Exclusion Criteria

• Known allergic reaction to labetalol
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental labetalol dose	Experimental dosing of labetalol	Subjects receive 40mg, 60mg, 80mg after each severe BP
Current standard of care	Standard dosing of labetalol	Subjects receive 20mg, 40mg, 60mg after each severe BP

Primary Outcome Measures

Name	Time	Method
Time to blood pressure control	This outcome will be measured during antepartum admission and will start with the first dose of IV labetalol given for severe blood pressure until subsequent blood pressure check is non-severe (<160 systolic and <110 diastolic), ending with delivery	length of time in minutes between IV labetalol treatment and non-severe blood pressure
Length of blood pressure control	This outcome will be measured during antepartum admission and will start with the first non-severe blood pressure after IV labetalol dosing until the next dose of IV labetalol is indicated (by severe blood pressure), ending with delivery	length of time in minutes between successful treatment resulting in non-severe blood pressure and need for next dose of IV labetalol

Secondary Outcome Measures

Name	Time	Method
Maternal adverse events	within 3 months of delivery	Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Neonatal adverse events	within 28 days of delivery	Any complications experienced by the neonate including APGAR score \< 5, need for respiratory support, blood glucose, death

Trial Locations

Locations (1)

Albany Medical Center Obstetrics and Gynecology; 🇺🇸 Albany, New York, United States