Clinical trial NCT03506724: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension in Pregnancy
Preeclampsia
Keywords: Hypertension, Pregnancy-induced
Pregnancy Induced Hypertension
Gestational Hypertension
Transient Hypertension, Pregnancy
Pharmacogenetics
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, New York
name: Maimonides Medical Center
First posted: 2018-04-24
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Time to Achieve Non Severe Range Blood Pressure
timeFrame: Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour
measure: Number of Participants to Achieve Non Severe Range Blood Pressure
timeFrame: up to 1 hour
Secondary outcomes:
measure: Frequency of Genetic Variants of Genes
timeFrame: up to 1 year
measure: Number of Participants With Medication Side Effects
timeFrame: assessed 10 minutes to 1 hour after medication is given
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Lois Brustman, MD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Howard Minkoff, MD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Poroshat Shekarloo, MD
role: PRINCIPAL_INVESTIGATOR
References: