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

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ClinicalTrials.gov Identifier: NCT00329511
Recruitment Status : Withdrawn (Feasibility of study. PI termination)
First Posted : May 24, 2006
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Afshan B. Hameed, M.D., University of California, Irvine

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: methyldopa vs. clonidine Drug: clonidine patch Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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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
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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
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United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Sponsors and Collaborators
Afshan B. Hameed, M.D.
Investigators
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Principal Investigator: Afshan B Hameed, MD University of California, Irvine
More Information
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Responsible Party: Afshan B. Hameed, M.D., Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00329511     History of Changes
Other Study ID Numbers: 200-04
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Keywords provided by Afshan B. Hameed, M.D., University of California, Irvine:
pregnancy
hypertension
compliance
clonidine patch
methyldopa
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Hypertension
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