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Acute Control of Chronic Hypertension (ACCTIVE)

Albany Medical College logo

Albany Medical College

Status and phase

Terminated
Phase 4

Conditions

Chronic Hypertension in Obstetric Context
Preeclampsia With Severe Features

Treatments

Other: Standard dosing of labetalol
Drug: Experimental dosing of labetalol

Study type

Interventional

Funder types

Other

Identifiers

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 history of preexisting hypertension, 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 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.

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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