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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
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.
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.
Albany Medical Center Obstetrics and Gynecology
Albany, New York, United States
Time to blood pressure control
length of time in minutes between IV labetalol treatment and non-severe blood pressure
Time frame: 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
Time frame: 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
Maternal adverse events
Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Time frame: 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
Time frame: within 28 days of delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.