Preeclampsia
Conditions
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.
Interventions
DRUGCelecoxib
Capsule, 200 mg/day until 32 weeks of gestation
DRUGPlacebo
Gelatin capsules of lactose
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length from start of treatment to delivery | From start of treatment to delivery |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure | From start of treatment to delivery |
| Proteinuria | From start of treatment to delivery |
| Maternal complications | From start of treatment to delivery |
| Prevalence of severe preeclampsia | From start of treatment to delivery |
| Gestational age at delivery | At time of delivery |
| Birth weight | At time of delivery |
| Fetal/neonatal status | From start of treatment to delivery |
Countries
United States
Outcome results
None listed