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

• Length of treatment to delivery
• Gestational age at delivery
• Birth weight

• Prevalence of severe preeclampsia [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
• Blood pressure [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
• Proteinuria [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
• Maternal complications [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
• Fetal/neonatal status [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
• Gestational age at delivery [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
• Birth weight [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]

• Prevalence of severe preeclampsia
• Blood pressure
• Proteinuria
• Maternal complications
• Fetal/neonatal status

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.

• Drug: Celecoxib
  Capsule, 200 mg/day until 32 weeks of gestation
  Other Name: Celebrex
• Drug: Placebo
  Gelatin capsules of lactose

• Experimental: 1
  Celecoxib, 200 mg/day
  Intervention: Drug: Celecoxib
• Placebo Comparator: 2
  Placebo
  Intervention: Drug: Placebo

• 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.
• Leik CE, Walsh SW. Neutrophils infiltrate resistance-sized vessels of subcutaneous fat in women with preeclampsia. Hypertension. 2004 Jul;44(1):72-7. Epub 2004 May 17.
• 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.

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.