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

Phase 2

Withdrawn

• Conditions: Preeclampsia
• Interventions: Drug: Placebo; Drug: Celecoxib

• Registration Number: NCT00442676
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-02
• Study Start: 2009-06
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Exclusion Criteria

• Exclusion criteria includes patients with known sensitivity to celecoxib; patients who have demonstrated allergic-type reactions to sulfonamides; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Other exclusion criteria will include patients with known cardiovascular disease or risk factors for cardiovascular disease, a prior history of ulcer disease or GI bleeding, impaired renal function, or liver dysfunction. Exclusion criteria will also include concomitant use of oral corticosteroids, anticoagulants, diuretics, ACE inhibitors, aspirin, fluconazole, and lithium.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Celecoxib	Celecoxib, 200 mg/day

Primary Outcome Measures

Name	Time	Method
Length from start of treatment to delivery	From start of treatment to delivery

Secondary Outcome Measures

Name	Time	Method
Prevalence of severe preeclampsia	From start of treatment to delivery
Blood pressure	From start of treatment to delivery
Proteinuria	From start of treatment to delivery
Maternal complications	From start of treatment to delivery
Fetal/neonatal status	From start of treatment to delivery
Gestational age at delivery	At time of delivery
Birth weight	At time of delivery

Trial Locations

Locations (1)

MCV Main Hospital; 🇺🇸 Richmond, Virginia, United States