Acute Control of Chronic Hypertension

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 history of preexisting hypertension, 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 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.

Official Title
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Acute Control of Chronic Hypertension in Preeclampsia

Conditions
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Preeclampsia With Severe Features, Chronic Hypertension in Obstetric Context

Intervention / Treatment
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* Drug: Experimental dosing of labetalol
* Other: Standard dosing of labetalol


Participation Criteria
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Eligibility Criteria
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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

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 after each severe BP | Drug: Experimental dosing of labetalol<br>* Subjects with preexisting hypertension 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, 60mg after each severe BP | Other: Standard dosing of labetalol<br>* Subjects with preexisting hypertension who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive either the standard of care 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 | length of time in minutes between IV labetalol treatment and non-severe blood pressure | 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 blood pressure control | length of time in minutes between successful treatment resulting in non-severe blood pressure and need for next dose of IV labetalol | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal adverse events | Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death | within 3 months of delivery | 
| Neonatal adverse events | Any complications experienced by the neonate including APGAR 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