Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-01-31

Brief Summary

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Preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and maternal morbidity and mortality. Recent findings indicate preeclampsia is an inflammatory disorder associated with increased expression of COX-2. This study will test the hypothesis that treatment of women with a COX-2 inhibitor, celecoxib, will stop the inflammatory process and reverse symptoms of preeclampsia.

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Detailed Description

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Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Celecoxib, 200 mg/day

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Capsule, 200 mg/day until 32 weeks of gestation

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Gelatin capsules of lactose

Interventions

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Celecoxib

Capsule, 200 mg/day until 32 weeks of gestation

Intervention Type DRUG

Placebo

Gelatin capsules of lactose

Intervention Type DRUG

Other Intervention Names

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Celebrex

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with preeclampsia between 20 - 32 weeks gestation. Preeclampsia is defined as a maternal blood pressure of \>140/90 mmHg on two readings at least 6 hours apart with proteinuria of \>300 mg/24 hours.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes