NCT00329511

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

4.3 years

First QC Date

May 22, 2006

Last Update Submit

January 26, 2018

Conditions

Hypertension

Keywords

pregnancyhypertensioncomplianceclonidine patchmethyldopa

Outcome Measures

Primary Outcomes (1)

  • Comparison of compliance

    4 weeks

Secondary Outcomes (1)

  • Side effects

    4 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

methyldopa

Drug: methyldopa vs. clonidineDrug: clonidine patch

B

ACTIVE COMPARATOR

clonidine patch

Drug: methyldopa vs. clonidineDrug: clonidine patch

Interventions

methyldopa vs. clonidineDRUG

Comparison of compliance

AB
clonidine patchDRUG

methyldopa 250 - 750 mg qid clonidine patch 0.1 - 0.4 mg q week

Also known as: aldomet, catapress tts
AB

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

HypertensionPatient Compliance

Interventions

Methyldopa

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Afshan B Hameed, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

September 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

US(1)