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Acute Labetalol Use in Preeclampsia (ALERT)

Albany Medical College logo

Albany Medical College

Status and phase

Terminated
Phase 4

Conditions

Preeclampsia With Severe Features

Treatments

Other: Current standard of care
Drug: Experimental labetalol dose

Study type

Interventional

Funder types

Other

Identifiers

NCT03872336
5254 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

15 participants in 2 patient groups

Experimental labetalol dose
Experimental group
Description:
Subjects receive 40mg, 60mg 80mg in succession after each severe BP
Treatment:
Drug: Experimental labetalol dose
Current standard of care
Active Comparator group
Description:
Subjects receive 20mg, 40mg 80mg in succession after each severe BP
Treatment:
Other: Current standard of care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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