Acute Control of Chronic Hypertension

Chronic Hypertension in Obstetric Context Clinical Trial

— ACCTIVE  

Official title:

Acute Control of Chronic Hypertension in Preeclampsia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03877692
• Other study ID #: 5253
• Status: Terminated
• Phase: Phase 4
• Start date: February 18, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: July 2020
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hypertension in Obstetric Context
• Hypertension
• Pre-Eclampsia
• Preeclampsia With Severe Features

Intervention

Drug:
• Experimental 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.

Other:
• Standard 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.

Locations

Country	Name	City	State
United States	Albany Medical Center Obstetrics and Gynecology	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (1)

Committee on Obstetric Practice. Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-5. doi: 10.1097/01.AOG.0000460762.59152.d7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to blood pressure control	length of time in minutes between IV labetalol treatment and non-severe blood pressure	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
Primary	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	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
Secondary	Maternal adverse events	Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death	within 3 months of delivery
Secondary	Neonatal adverse events	Any complications experienced by the neonate including APGAR score < 5, need for respiratory support, blood glucose, death	within 28 days of delivery