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Acute Labetalol Use in Preeclampsia (ALERT)

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ClinicalTrials.gov Identifier: NCT03872336
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Albany Medical College

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Time to blood pressure control [ Time Frame: 4 hours after last labetalol dosing ]
The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Differences in racial response [ Time Frame: 4 hours after last labetalol dosing ]
    The difference in time for blood pressure control amongst racial groups
  • Maternal adverse events [ Time Frame: within 3 months of delivery ]
    Anticipated and unanticipated maternal events including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death
  • Neonatal adverse events [ Time Frame: within 28 days of delivery ]
    complications experienced by the neonate including PGAR score < 5, need for respiratory support, blood glucose, death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Labetalol Use in Preeclampsia
Official Title  ICMJE Acute Labetalol Use in Preeclampsia Randomized Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
The principle investigator and outcomes assessor are masked to group assignment.
Primary Purpose: Treatment
Condition  ICMJE Preeclampsia With Severe Features
Intervention  ICMJE
  • Drug: Experimental labetalol dose
    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.
  • Other: Current standard of care
    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.
Study Arms  ICMJE
  • Experimental: Experimental labetalol dose
    Subjects receive 40mg, 60mg 80mg in succession after each severe BP
    Intervention: Drug: Experimental labetalol dose
  • Active Comparator: Current standard of care
    Subjects receive 20mg, 40mg 80mg in succession after each severe BP
    Intervention: Other: Current standard of care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Asha Rijhsinghani 518.262.4942 rijhsia@amc.edu
Contact: Yiwen Cui 832.788.8154 cuiy@amc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03872336
Other Study ID Numbers  ICMJE 5254
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Albany Medical College
Study Sponsor  ICMJE Albany Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Albany Medical College
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP