Preeclampsia With Severe Features
Conditions
Keywords
Hypertension, Labetalol, Obesity
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 body-mass index, 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 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.
Interventions
DRUGExperimental labetalol dose
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.
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to blood pressure control | 4 hours after last labetalol dosing | The length of time the subject continued to have non-severe range blood pressure following administration of labetolol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in racial response | 4 hours after last labetalol dosing | The difference in time for blood pressure control amongst racial groups |
| Maternal adverse events | within 3 months of delivery | Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death |
| Neonatal adverse events | within 28 days of delivery | complications experienced by the neonate including PGAR score \< 5, need for respiratory support, blood glucose, death |
Countries
United States
Outcome results
None listed