Back to resultsAcute Labetalol Use in Preeclampsia (ALERT)
Primary Purpose
Preeclampsia With Severe Features
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Experimental labetalol dose
Current standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia With Severe Features focused on measuring Hypertension, Labetalol, Obesity
Eligibility Criteria
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
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 in succession after each severe BP
Subjects receive 20mg, 40mg 80mg in succession after each severe BP
Outcomes
Primary Outcome Measures
Time to blood pressure control
The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.
Secondary Outcome Measures
Differences in racial response
The difference in time for blood pressure control amongst racial groups
Maternal adverse events
Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Neonatal adverse events
complications experienced by the neonate including PGAR score < 5, need for respiratory support, blood glucose, death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03872336
Brief Title
Acute Labetalol Use in Preeclampsia
Acronym
ALERT
Official Title
Acute Labetalol Use in Preeclampsia Randomized Trial
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia With Severe Features
Keywords
Hypertension, Labetalol, Obesity
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
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental labetalol dose
Arm Type
Experimental
Arm Description
Subjects receive 40mg, 60mg 80mg in succession after each severe BP
Arm Title
Current standard of care
Arm Type
Active Comparator
Arm Description
Subjects receive 20mg, 40mg 80mg in succession after each severe BP
Intervention Type
Drug
Intervention Name(s)
Experimental labetalol dose
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Current standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to blood pressure control
Description
The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.
Time Frame
4 hours after last labetalol dosing
Secondary Outcome Measure Information:
Title
Differences in racial response
Description
The difference in time for blood pressure control amongst racial groups
Time Frame
4 hours after last labetalol dosing
Title
Maternal adverse events
Description
Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
Time Frame
within 3 months of delivery
Title
Neonatal adverse events
Description
complications experienced by the neonate including PGAR 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:
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
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
result
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Acute Labetalol Use in Preeclampsia
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