Chronic Hypertension in Obstetric Context, Preeclampsia With Severe Features
Conditions
Keywords
Hypertension, Labetalol
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.
Interventions
DRUGExperimental dosing of labetalol
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.
OTHERStandard dosing of labetalol
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.
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principle investigator and outcomes assessor are masked to group assignment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed