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

Study Overview
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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.

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Placebo


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Celecoxib, 200 mg/day | Drug: Celecoxib<br>* Capsule, 200 mg/day until 32 weeks of gestation<br>* Other names: Celebrex;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Gelatin capsules of lactose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length from start of treatment to delivery |  | From start of treatment to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |