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Response to Anti-hypertensives in Pregnant and Postpartum Patients

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ClinicalTrials.gov Identifier: NCT03506724
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
Mount Sinai Hospital, New York
Maimonides Medical Center
Information provided by (Responsible Party):
Dyese Taylor, Icahn School of Medicine at Mount Sinai

Brief Summary:
In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG). In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and similar genes involved in beta blockade, genes involved in calcium channel blockade and other genes implicated in blood pressure response among pregnant and postpartum patients receiving labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic association exists between variant alleles in these receptors in the pregnant and postpartum population.

Condition or disease Intervention/treatment Phase
Hypertension in Pregnancy Preeclampsia Drug: Nifedipine Drug: Labetalol Phase 4

Detailed Description:

Hypertensive disease in pregnancy is a major cause of maternal morbidity and mortality. This condition is responsible for about 12% of the maternal deaths in the United States.

Currently, if pregnant patients present with severe hypertension they are either given IV labetalol, IV hydralazine of nifedipine based on individual provider preference. There are few studies in the literature comparing oral nifedipine and IV labetalol with mixed data showing either they are equally effective or a faster time to achieving target blood pressure for patients who received nifedipine.

In this study, the investigators will evaluate if there is a difference in time to achieve goal blood pressure in pregnant and postpartum patients who are treated with nifedipine and labetalol for severe range blood pressures defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients who present to the hospitals in this study will be randomized to receive IV labetalol or oral nifedipine when presenting with persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic. These anti-hypertensives are first line therapy for management of severe range blood pressures by the American Congress of Obstetricians and Gynecologists.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ethnic Differences in Anti-Hypertensive Medication Response Among Pregnant and Postpartum Patients
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Oral nifedipine
Oral medication 10mg and 20mg
Drug: Nifedipine
Nifedipine 10mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given and institution specific protocol will be performed.

Intravenous labetalol
intravenous medication 20mg, 40mg, 80 mg
Drug: Labetalol
Labetalol 20mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication will be chosen based on institution specific protocol.




Primary Outcome Measures :
  1. Change in time to achieve non severe range blood pressure [ Time Frame: Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour ]
    Change in time to achieve non severe range blood pressures after IV labetalol or oral nifedipine is given to patients with severe range blood pressures.


Secondary Outcome Measures :
  1. Frequency of genetic variants of genes [ Time Frame: up to 1 year ]
    the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population.

  2. Rate of Side effects [ Time Frame: assessed 10 minutes to 1 hour after medication is given ]
    The rate of side effects from IV labetalol and oral nifedipine



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant patients from 20 weeks to up to 6 weeks postpartum
  • between the ages of 18-55.
  • persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.

Exclusion Criteria:

  • multiple gestation
  • patients with non-reassuring fetal heart rate (category 3)
  • patients with abruptio placenta
  • patients with renal impairment
  • history of heart failure
  • history of cardiac arrhythmia
  • use of anti-hypertensive medications in the past 24 hours
  • patients with allergies or medical contraindications to labetalol or nifedipine.

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): NCT03506724


Contacts
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Contact: Dyese Taylor, MD 212-523-6148 dyese.taylor@mountsinai.org

Locations
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United States, New York
Maimonides Hospital Recruiting
Brooklyn, New York, United States, 11219
Contact: Poroshat Shekarloo, MD       pshekarloo@maimonidesmed.org   
Mount Sinai West Recruiting
New York, New York, United States, 10019
Contact: Dyese Taylor, MD    212-523-7579    dyese.taylor@mountsinai.org   
Principal Investigator: Dyese Taylor, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Mount Sinai Hospital, New York
Maimonides Medical Center
Investigators
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Study Director: Lois Brustman, MD Icahn School of Medicine at Mount Sinai
Study Director: Howard Minkoff, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Poroshat Shekarloo, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Dyese Taylor, Principal Investigator, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03506724     History of Changes
Other Study ID Numbers: GCO 17-0257
Maimonides IRB 2018-02-17 ( Other Identifier: Maimonides IRB/Research Committee )
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 Dyese Taylor, Icahn School of Medicine at Mount Sinai:
Hypertension, Pregnancy-induced
Pregnancy Induced Hypertension
Gestational Hypertension
Transient Hypertension, Pregnancy
Pharmacogenetics

Additional relevant MeSH terms:
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Hypertension
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Nifedipine
Labetalol
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists