A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy
Status:
Withdrawn
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Afshan B. Hameed, M.D. University of California, Irvine