We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Inadequate Enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329511
First Posted: May 24, 2006
Last Update Posted: December 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Irvine
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Comparison of compliance [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Intrauterine pregnancy between 14 - 28 weeks of gestation
  2. Chronic hypertension requiring antihypertensive therapy (BP < 180/110)
  3. Subjects who consent to the study
  4. No evidence of fetal compromise (i.e. intrauterine growth restriction)

Exclusion Criteria:

  1. Evidence or suspicion of preeclampsia
  2. Known cardiac disease
  3. Known renal dysfunction (creatinine > 1 mg/dl)
  4. Known hepatic disease
  5. Known cerebrovascular disease
  6. Allergy to clonidine patch
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 22, 2006
First Posted: May 24, 2006
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by University of California, Irvine:
pregnancy
hypertension
compliance
clonidine patch
methyldopa

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pregnancy Complications
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
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