A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy - Full Text View

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00329511

Purpose

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
Hypertension	Drug: methyldopa vs. clonidine Drug: clonidine patch

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Clonidine Clonidine hydrochloride Methyldopa Methyldopa ethyl ester hydrochloride Methyldopate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Comparison of compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2008
Estimated 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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329511

Contacts

Contact: Afshan B Hameed, MD

(714) 456-7879

ahameed@uci.edu

Locations

United States, California
Long Beach Memorial Medical Center	Recruiting
Long Beach, California, United States, 90806
Contact: Afshan B Hameed, MD
Principal Investigator: Afshan B Hameed, MD

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Afshan B Hameed, MD

University of California, Irvine

More Information

Responsible Party:	UCaliforniaIrvine ( Afshan Hameed, M.D. )
Study ID Numbers:	200-04
Study First Received:	May 22, 2006
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00329511
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

pregnancy
hypertension
compliance
clonidine patch
methyldopa

Study placed in the following topic categories:

Clonidine
Vascular Diseases
Methyldopa
Hypertension

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists

Pharmacologic Actions
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009