Acute Labetalol Use in Preeclampsia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Labetalol Use in Preeclampsia Randomized Trial

Conditions
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Preeclampsia With Severe Features

Intervention / Treatment
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* Drug: Experimental labetalol dose
* Other: Current standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental labetalol dose<br>Subjects receive 40mg, 60mg 80mg in succession after each severe BP | Drug: Experimental labetalol dose<br>* 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.<br>|
| Active Comparator: Current standard of care<br>Subjects receive 20mg, 40mg 80mg in succession after each severe BP | Other: Current standard of care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Labetalol, Obesity