Response to Anti-hypertensives in Pregnant and Postpartum Patients

Completed · Phase 4

Conditions studied: Hypertension in Pregnancy, Preeclampsia

In brief

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.

Key facts

Study ID

NCT03506724

Run by

Icahn School of Medicine at Mount Sinai

People needed

109

Starts

2017-09-11

Expected to finish

2019-04-05

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Maimonides Hospital — Brooklyn, New York, United States
• Mount Sinai West — New York, New York, United States

Full record on ClinicalTrials.gov

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