A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Comparison of compliance
研究概览
简要总结
High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited.
Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period.
The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
详细描述
Purpose of the Study:
The purpose of this of open-label randomized clinical trial is to compare clonidine patch (Catapres-TTS®) and orally administered methyldopa (Aldomet®) over a 4-week period for compliance in pregnant women between 14 and 28 weeks of gestation. In addition, this study will evaluate blood pressure (BP) control, patient tolerability, and development of side effects to each medication. Patients will be alternately randomized to receive methyldopa (standard of care) or clonidine patch.
Hypothesis:
Clonidine is an effective antihypertensive agent with similar mechanism of action to methyldopa. Transdermal clonidine may provide a better compliance profile, adequate BP control and, therefore, may be used as an alternative to methyldopa for the treatment of CHTN in pregnancy.
Primary outcome of the study is patient compliance. Compliance will be measured via patient diary, promptness of keeping appointments, and pill/patch counts at each visit. Overall compliance will be calculated over a 4 week study period by adding compliance points for each visit as outlined in the data sheet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Intrauterine pregnancy between 14 - 28 weeks of gestation
- •Chronic hypertension requiring antihypertensive therapy (BP < 180/110)
- •Subjects who consent to the study
- •No evidence of fetal compromise (i.e. intrauterine growth restriction)
排除标准
- •Evidence or suspicion of preeclampsia
- •Known cardiac disease
- •Known renal dysfunction (creatinine > 1 mg/dl)
- •Known hepatic disease
- •Known cerebrovascular disease
- •Allergy to clonidine patch
研究组 & 干预措施
B
clonidine patch
干预措施: clonidine patch (Drug)
A
methyldopa
干预措施: methyldopa vs. clonidine (Drug)
A
methyldopa
干预措施: clonidine patch (Drug)
B
clonidine patch
干预措施: methyldopa vs. clonidine (Drug)
结局指标
主要结局
Comparison of compliance
时间窗: 4 weeks
次要结局
- Side effects(4 weeks)
研究者
Afshan B. Hameed, M.D.
Associate Professor
University of California, Irvine