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NCT Number: NCT03506724

Response to Anti-hypertensives in Pregnant and Postpartum Patients

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Maimonides Hospital, Brooklyn, New York, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nifedipine

Drug

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.

labetalol

Drug

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 outcomes

  1. 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

    Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.

  2. Number of Participants to Achieve Non Severe Range Blood Pressure

    Time frame: up to 1 hour

    Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.

Secondary outcomes

  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. Number of Participants With Medication Side Effects

    Time frame: assessed 10 minutes to 1 hour after medication is given

    Number of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Maimonides Medical Center
  • Mount Sinai Hospital, New York

Registry information

Official study title

Ethnic Differences in Anti-Hypertensive Medication Response Among Pregnant and Postpartum Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2018
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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