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No patients were recruited. Treatment drug expired.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Celecoxib, 200 mg/day |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Capsule, 200 mg/day until 32 weeks of gestation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Length from start of treatment to delivery | From start of treatment to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of severe preeclampsia | From start of treatment to delivery | |
| Blood pressure | From start of treatment to delivery | |
| Proteinuria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott W Walsh, PhD | Virginia Commonwealth University | Principal Investigator |
| Susan M Lanni, MD | Virginia Commonwealth University | Study Director |
| Fidelma B Rigby, MD | Virginia Commonwealth University | Study Director |
| Nicole W Karjane, MD | Virginia Commonwealth University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCV Main Hospital | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17240230 | Background | Shah TJ, Walsh SW. Activation of NF-kappaB and expression of COX-2 in association with neutrophil infiltration in systemic vascular tissue of women with preeclampsia. Am J Obstet Gynecol. 2007 Jan;196(1):48.e1-8. doi: 10.1016/j.ajog.2006.08.038. | |
| 15148293 | Background | Leik CE, Walsh SW. Neutrophils infiltrate resistance-sized vessels of subcutaneous fat in women with preeclampsia. Hypertension. 2004 Jul;44(1):72-7. doi: 10.1161/01.HYP.0000130483.83154.37. Epub 2004 May 17. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Gelatin capsules of lactose |
|
| 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 |
| 15924527 | Background | Groom KM, Shennan AH, Jones BA, Seed P, Bennett PR. TOCOX--a randomised, double-blind, placebo-controlled trial of rofecoxib (a COX-2-specific prostaglandin inhibitor) for the prevention of preterm delivery in women at high risk. BJOG. 2005 Jun;112(6):725-30. doi: 10.1111/j.1471-0528.2005.00539.x. |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |