Ignite Creation Date:
2024-05-06 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03506724
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2018-04-13
Brief Title:
Response to Anti-hypertensives in Pregnant and Postpartum Patients
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Ethnic Differences in Anti-Hypertensive Medication Response Among Pregnant and Postpartum Patients
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 160110 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 160110 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
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 160110 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Maimonides IRB 2018-02-17 | OTHER | Maimonides IRBResearch Committee | None |