Back to resultsAcute Control of Chronic Hypertension (ACCTIVE)
Primary Purpose
Preeclampsia With Severe Features, Chronic Hypertension in Obstetric Context
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Experimental dosing of labetalol
Standard dosing of labetalol
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia With Severe Features focused on measuring Hypertension, Labetalol
Eligibility Criteria
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
Sites / Locations
- Albany Medical Center Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental labetalol dose
Current standard of care
Arm Description
Subjects receive 40mg, 60mg, 80mg after each severe BP
Subjects receive 20mg, 40mg, 60mg after each severe BP
Outcomes
Primary Outcome Measures
Time to blood pressure control
length of time in minutes between IV labetalol treatment and non-severe blood pressure
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
Secondary Outcome Measures
Maternal adverse events
Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Neonatal adverse events
Any complications experienced by the neonate including APGAR score < 5, need for respiratory support, blood glucose, death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03877692
Brief Title
Acute Control of Chronic Hypertension
Acronym
ACCTIVE
Official Title
Acute Control of Chronic Hypertension in Preeclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albany Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 history of preexisting hypertension, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia With Severe Features, Chronic Hypertension in Obstetric Context
Keywords
Hypertension, Labetalol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The principle investigator and outcomes assessor are masked to group assignment.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental labetalol dose
Arm Type
Experimental
Arm Description
Subjects receive 40mg, 60mg, 80mg after each severe BP
Arm Title
Current standard of care
Arm Type
Active Comparator
Arm Description
Subjects receive 20mg, 40mg, 60mg after each severe BP
Intervention Type
Drug
Intervention Name(s)
Experimental dosing of labetalol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard dosing of labetalol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to blood pressure control
Description
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
Title
Length of blood pressure control
Description
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
Secondary Outcome Measure Information:
Title
Maternal adverse events
Description
Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Time Frame
within 3 months of delivery
Title
Neonatal adverse events
Description
Any complications experienced by the neonate including APGAR score < 5, need for respiratory support, blood glucose, death
Time Frame
within 28 days of delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Albany Medical Center Obstetrics and Gynecology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25611642
Citation
Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-525. doi: 10.1097/01.AOG.0000460762.59152.d7.
Results Reference
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Acute Control of Chronic Hypertension
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