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临床试验/NCT03105661
NCT03105661
Unknown
早期 1 期

Use of Impedance Cardiography to Decrease the Risk of Preeclampsia in Obese Patients

University of Tennessee Graduate School of Medicine1 个研究点 分布在 1 个国家目标入组 400 人2017年4月4日

概览

阶段
早期 1 期
干预措施
Labetalol Hydrochloride 200 mg
疾病 / 适应症
Obesity, Morbid
发起方
University of Tennessee Graduate School of Medicine
入组人数
400
试验地点
1
主要终点
Rates of preeclampsia in morbidly obese pregnant women
最后更新
7年前

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. Randomization: All patients who meet criteria will undergo impedance cardiography. Those with abnormal results will be randomized as the whether they will be treated or not. Randomization will require they blindly pull a paper labelled "yes" or "no" from a container. Those who select "yes" will be randomized to the treatment arm and will be prescribed antihypertensive medications commonly used in obstetrics for hypertension (labetalol, nifedipine, atenolol) Those who select "no" will not receive medication. Study Procedure: All pregnant patients that meet study criteria and have abnormal Impedance Cardiography testing will be asked to participate, consented and randomized to the treatment or non treatment arm. The treatment group will receive antihypertensive medications as listed above and undergo monthly cardiography testing after beginning treatment with medication adjustments until normal test results are obtained. The non treatment group will undergo repeat cardiography testing 8 weeks after the first test to compare results. All enrolled patients will be followed with regular prenatal care for their prospective conditions and followed closely for the development of high or low blood pressure and preeclampsia. Adverse events: Adverse events related to this study are minimal because the test is non invasive and complications for Impedance Cardiology are non existent. In addition, the drugs used to treat hypertension have been used in obstetrics for over 30 years with good results and minimal problems.

注册库
clinicaltrials.gov
开始日期
2017年4月4日
结束日期
2020年3月4日
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

发起方
University of Tennessee Graduate School of Medicine
责任方
Principal Investigator
主要研究者

Mary Ellen McNeal

Research Coordinator

University of Tennessee Graduate School of Medicine

入排标准

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

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

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

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

研究点 (1)

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