A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy
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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 |
- Comparison of compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- 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:
|
|
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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| United States, California | |
| Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90806 | |
| Principal Investigator: | Afshan B Hameed, MD | University of California, Irvine |
More Information
No publications provided
| 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: | February 6, 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 Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013