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CLINICAL TRIALS PROFILE FOR METHYLDOPA

Clinical Trials for Methyldopa

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00117546	Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia	Unknown status	Radboud University	Phase 4	A history of preeclampsia is associated with a low plasma volume and higher sympathetic activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the researchers will test that effect on the total cardiovascular balance.
NCT00157521	L-Arginine in Pre-Eclampsia	Completed	Mario Negri Institute for Pharmacological Research	Phase 3	Pre-eclampsia is a disorder unique to pregnancy affecting both the mother and the fetus. Hypertension, proteinuria and edema are the most common and well-known maternal clinical symptoms. The incidence is approximately 6-8%. Pre-eclampsia is one of the leading causes of maternal and fetal mortality and morbidity associated with pregnancy throughout the world. The pathophysiology is unknown. At present, the most effective treatment is immediate delivery. The researchers' studies contributed to the demonstration that the vasodilator nitric oxide (NO) is important for correct placentation and that less nitric oxide (NO)- dependent vasodilation and an excess formation of reactive oxygen species explain poor placenta perfusion in pre-eclampsia. This reduced NO activity and increased oxidative stress in pre-eclamptic placenta is related to low bioavailability of L-arginine, the NO precursor. In this pilot study the researchers want to evaluate whether the administration of L-arginine to women with a clinical diagnosis of preeclampsia might restore physiological NO production in the placenta and ameliorate the pregnancy outcome.
NCT00194974	Treatment Targets for Chronic Hypertension in Pregnancy	Unknown status	Weill Medical College of Cornell University	Phase 1/Phase 2	This project is a clinical study of women with high blood pressure who become pregnant. Preeclampsia is a syndrome developing at the end of a pregnancy characterized by an abrupt rise in blood pressure (BP), blood clotting and kidney dysfunction, and may result in premature delivery, infant death, and maternal bleeding, kidney failure and stroke. The goal is to determine whether lowering blood pressure to a normal pressure of 120/80 is associated with a lower incidence of preeclampsia. Women who are completely healthy have a 5% chance of developing preeclampsia, however women with preexisting high blood pressure have a 25% chance of this complication. Several studies, including our own suggest that higher blood pressure early in pregnancy (<20 weeks) is associated with an even higher risk of preeclampsia. Currently we, the researchers at Weill Medical College of Cornell University, do not know how to treat women with high blood pressure and/or kidney disease during pregnancy. Keeping the BP in the normal range may be beneficial to the mother. On the other hand, we are not sure if the blood pressure lowering or the medications may or may not have adverse effects for the baby. Different trials to answer this question have been performed with no clear conclusions. Because of these uncertainties, we propose to compare two different strategies for treating women with high BP who become pregnant. We will treat half the women with BP medications to normalize BP (120-130/80 mm Hg) (experimental group) and the other half with the goal of keeping the BP slightly higher (140-150/90-100 mm Hg)(standard therapy group). We will determine which approach results in healthier pregnancies, and lower incidence of preeclampsia. Reducing the incidence of preeclampsia would be of significant benefit to both mothers and babies.
NCT00329511	A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy	Terminated	University of California, Irvine	N/A	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.
NCT01361425	Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia (Metildopape)	Unknown status	Conselho Nacional de Desenvolvimento Científico e Tecnológico	Phase 4	Introduction: Hypertensive emergency in pregnant women with pre-eclampsia should be treated for preventing stroke and placental abruption. However, the benefit of antihypertensive medication maintenance remains unclear, mainly due to the potential risk of fetal growth restriction.
NCT01361425	Anti-Hypertensive Treatment In Stable Pregnant Women With Severe Pre-Eclampsia (Metildopape)	Unknown status	Professor Fernando Figueira Integral Medicine Institute	Phase 4	Introduction: Hypertensive emergency in pregnant women with pre-eclampsia should be treated for preventing stroke and placental abruption. However, the benefit of antihypertensive medication maintenance remains unclear, mainly due to the potential risk of fetal growth restriction.
NCT01674127	Effect of Methyldopa on Uterine Artery Diameter in Pregnant Women With Mild Preeclampsia	Completed	Isfahan University of Medical Sciences	Phase 2	The present study examined the effects of Methyldopa on uterine artery diameter, uterine artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with Preeclampsia, using Doppler ultrasound.
Trial ID	Title	Status	Sponsor	Phase	Summary