Response to Anti-hypertensives in Pregnant and Postpartum Patients

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506724
• Other study ID #: GCO 17-0257
• Secondary ID: Maimonides IRB 2
• Status: Completed
• Phase: Phase 4
• Start date: September 11, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: April 2021
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Maimonides Hospital	Brooklyn	New York
United States	Mount Sinai West	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Maimonides Medical Center, Mount Sinai Hospital, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Achieve Non Severe Range Blood Pressure	Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.	Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour
Primary	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.	up to 1 hour
Secondary	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.	up to 1 year
Secondary	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	assessed 10 minutes to 1 hour after medication is given