Ethnic Differences in Anti-Hypertensive Medication Response Among Pregnant and Postpartum Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Time to Achieve Non Severe Range Blood Pressure
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant patients from 20 weeks to up to 6 weeks postpartum
- •between the ages of 18-
- •persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.
排除标准
- •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.
研究组 & 干预措施
Oral nifedipine
Oral medication 10mg and 20mg
干预措施: Nifedipine (Drug)
Intravenous labetalol
intravenous medication 20mg, 40mg, 80 mg
干预措施: Labetalol (Drug)
结局指标
主要结局
Time to Achieve Non Severe Range Blood Pressure
时间窗: 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.
Number of Participants to Achieve Non Severe Range Blood Pressure
时间窗: up to 1 hour
Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
次要结局
- Number of Participants With Medication Side Effects(assessed 10 minutes to 1 hour after medication is given)
- Frequency of Genetic Variants of Genes(up to 1 year)
研究者
Dyese Taylor
Principal Investigator
Icahn School of Medicine at Mount Sinai