Response to Anti-hypertensives in Pregnant and Postpartum Patients
Primary Purpose
Hypertension in Pregnancy, Preeclampsia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nifedipine
Labetalol
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension in Pregnancy focused on measuring Hypertension, Pregnancy-induced, Pregnancy Induced Hypertension, Gestational Hypertension, Transient Hypertension, Pregnancy, Pharmacogenetics
Eligibility 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.
Sites / Locations
- Maimonides Hospital
- Mount Sinai West
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Oral nifedipine
Intravenous labetalol
Arm Description
Oral medication 10mg and 20mg
intravenous medication 20mg, 40mg, 80 mg
Outcomes
Primary Outcome Measures
Time to Achieve Non Severe Range Blood Pressure
Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Number of Participants to Achieve Non Severe Range Blood Pressure
Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Secondary Outcome Measures
Frequency of Genetic Variants of Genes
the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population.
Number of Participants With Medication Side Effects
Number of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine
Full Information
NCT ID
NCT03506724
First Posted
April 13, 2018
Last Updated
April 30, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Mount Sinai Hospital, New York, Maimonides Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03506724
Brief Title
Response to Anti-hypertensives in Pregnant and Postpartum Patients
Official Title
Ethnic Differences in Anti-Hypertensive Medication Response Among Pregnant and Postpartum Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Mount Sinai Hospital, New York, Maimonides Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Preeclampsia
Keywords
Hypertension, Pregnancy-induced, Pregnancy Induced Hypertension, Gestational Hypertension, Transient Hypertension, Pregnancy, Pharmacogenetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral nifedipine
Arm Type
Other
Arm Description
Oral medication 10mg and 20mg
Arm Title
Intravenous labetalol
Arm Type
Other
Arm Description
intravenous medication 20mg, 40mg, 80 mg
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Labetalol
Intervention Description
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 Measure Information:
Title
Time to Achieve Non Severe Range Blood Pressure
Description
Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Time Frame
Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour
Title
Number of Participants to Achieve Non Severe Range Blood Pressure
Description
Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Time Frame
up to 1 hour
Secondary Outcome Measure Information:
Title
Frequency of Genetic Variants of Genes
Description
the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population.
Time Frame
up to 1 year
Title
Number of Participants With Medication Side Effects
Description
Number of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine
Time Frame
assessed 10 minutes to 1 hour after medication is given
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lois Brustman, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Howard Minkoff, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Poroshat Shekarloo, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Response to Anti-hypertensives in Pregnant and Postpartum Patients
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