Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rates of preeclampsia in morbidly obese pregnant women
研究概览
简要总结
To determine if the use of impedance cardiography can identify appropriate medications for use in treating morbidly obese patients to decrease the risk of preeclampsia.
详细描述
Research Protocol
Use of Impedance Cardiography to decrease the risk of preeclampsia in obese patients
Background: Obesity is epidemic in the United States and this is leading to an increase in the number of pregnant patients with obesity. Obesity, especially morbid obesity (BMI >/= 40), increases the risk of developing preeclampsia when compared to the non-obese population. Impedance Cardiography has never been used to evaluate this patient population to see if they have abnormal cardiac output and/or abnormal peripheral resistance. If identified, low dose medical treatment can be done to normalize these patterns early on to see if this treatment modality decreases the development of preeclampsia and other pregnancy complications.
Specific Aims: The primary aim of this study is to determine if the use of Impedance Cardiography can help identify the appropriate medicine for use in treating morbidly obese patients that have abnormal testing results, to see if by normalizing impedance cardiography testing parameters results in a decrease in the incidence of preeclampsia in general and other pregnancy complications.
Enrollment: All pregnant patients, 18-51 years old, less than 20 weeks pregnant, with a BMI >/= 40 will undergo impedance cardiography and if the results are abnormal, will be provided informed consent to participate. If consent is given, and blood pressure is < 140/90,they will be eligible for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients 18-51 years old,
- •Less than 20 weeks gestation with Morbid Obesity (BMI >/= 40)
- •Not on antihypertensive medications
排除标准
- •Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy
- •Patients who have a blood pressure 140/90 or greater
研究组 & 干预措施
Treatment Arm
Patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.
Labetalol Hydrochloride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily
干预措施: Labetalol Hydrochloride 200 mg (Drug)
Treatment Arm
Patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.
Labetalol Hydrochloride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily
干预措施: Atenolol 25 mg (Drug)
Treatment Arm
Patients will be randomized to treatment with antihypertensive medications used with pregnancy for thirty years.
Labetalol Hydrochloride 200 mg orally every 12 hours Nifedipine 60 mg orally daily Atenolol 25 mg daily
干预措施: NIFEdipine 60 mg (Drug)
结局指标
主要结局
Rates of preeclampsia in morbidly obese pregnant women
时间窗: 2 years
Rates of preeclampsia in morbidly obese pregnant women
次要结局
未报告次要终点
研究者
Mary Ellen McNeal
Research Coordinator
University of Tennessee Graduate School of Medicine