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

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy

Resource links provided by NLM:

Genetics Home Reference related topics: preeclampsia

MedlinePlus related topics: High Blood Pressure in Pregnancy

Drug Information available for: Methyldopa Methyldopate hydrochloride Clonidine Clonidine hydrochloride

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

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 ]


Enrollment:	2
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
Active Comparator: A 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 Other Names: aldomet catapress tts
Active Comparator: B 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 Other Names: aldomet catapress tts

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806

Sponsors and Collaborators

University of California, Irvine

Investigators


Principal Investigator:	Afshan B Hameed, MD	University of California, Irvine

More Information


Responsible Party:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00329511 History of Changes
Other Study ID Numbers:	200-04
Study First Received:	May 22, 2006
Last Updated:	December 9, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:


pregnancy hypertension compliance clonidine patch methyldopa

Additional relevant MeSH terms:


Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Vascular Diseases Cardiovascular Diseases Pregnancy Complications Clonidine Methyldopa Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Antihypertensive Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016