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Trial record 24 of 31 for:    "Preeclampsia/eclampsia 1" | "Antihypertensive Agents"

Acute Control of Chronic Hypertension (ACCTIVE)

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ClinicalTrials.gov Identifier: NCT03877692
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Preeclampsia With Severe Features Chronic Hypertension in Obstetric Context Drug: Experimental dosing of labetalol Other: Standard dosing of labetalol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
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
Official Title: Acute Control of Chronic Hypertension in Preeclampsia
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : July 1, 2021


Arm Intervention/treatment
Experimental: Experimental labetalol dose
Subjects receive 40mg, 60mg, 80mg after each severe BP
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.

Active Comparator: Current standard of care
Subjects receive 20mg, 40mg, 60mg after each severe BP
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.




Primary Outcome Measures :
  1. Time to blood pressure control [ 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 ]
    length of time in minutes between IV labetalol treatment and non-severe blood pressure

  2. Length of blood pressure control [ 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 ]
    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 :
  1. Maternal adverse events [ Time Frame: within 3 months of delivery ]
    Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death

  2. Neonatal adverse events [ Time Frame: within 28 days of delivery ]
    Any complications experienced by the neonate including APGAR score < 5, need for respiratory support, blood glucose, death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877692


Contacts
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Contact: Johanna Bringley, DO 518.262.4942 bringlj@amc.edu
Contact: Yiwen Cui, MD 8327888154 cuiy@mail.amc.edu

Locations
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United States, New York
Albany Medical Center Obstetrics and Gynecology Recruiting
Albany, New York, United States, 12208
Contact: OBGYN Research Director, MD    518-262-4942    obgynresearch@amc.edu   
Sponsors and Collaborators
Albany Medical College

Publications:
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Responsible Party: Albany Medical College
ClinicalTrials.gov Identifier: NCT03877692     History of Changes
Other Study ID Numbers: 5253
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Albany Medical College:
Hypertension
Labetalol
Additional relevant MeSH terms:
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Pre-Eclampsia
Antihypertensive Agents
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Labetalol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists