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Sponsored by: |
University of California, Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00329511 |
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.
Condition | Intervention |
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Hypertension |
Drug: methyldopa vs. clonidine Drug: clonidine patch |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy |
Estimated Enrollment: | 58 |
Study Start Date: | September 2004 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
methyldopa
|
Drug: methyldopa vs. clonidine
Comparison of compliance
Drug: clonidine patch
methyldopa 250 - 750 mg qid clonidine patch 0.1 - 0.4 mg q week
|
B: Active Comparator
clonidine patch
|
Drug: methyldopa vs. clonidine
Comparison of compliance
Drug: clonidine patch
methyldopa 250 - 750 mg qid clonidine patch 0.1 - 0.4 mg q week
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Long Beach Memorial Medical Center | |
Long Beach, California, United States, 90806 |
Principal Investigator: | Afshan B Hameed, MD | University of California, Irvine |
Responsible Party: | UCaliforniaIrvine ( Afshan Hameed, M.D. ) |
Study ID Numbers: | 200-04 |
Study First Received: | May 22, 2006 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00329511 History of Changes |
Health Authority: | United States: Institutional Review Board |
pregnancy hypertension compliance clonidine patch methyldopa |
Neurotransmitter Agents Pregnancy Complications Adrenergic alpha-Agonists Eclampsia Adrenergic Agents Clonidine Vascular Diseases Pre-Eclampsia Methyldopa |
Cardiovascular Agents Antihypertensive Agents Preeclampsia Adrenergic Agonists Hypertension, Pregnancy-Induced Peripheral Nervous System Agents Analgesics Hypertension |
Sympatholytics Neurotransmitter Agents Pregnancy Complications Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Clonidine Vascular Diseases Pre-Eclampsia Methyldopa Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Adrenergic Agonists Hypertension, Pregnancy-Induced Autonomic Agents Sensory System Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Analgesics Central Nervous System Agents Hypertension |