Clinical trial NCT00442676: Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Official title: Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Preeclampsia
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2007-03-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Length from start of treatment to delivery
timeFrame: From start of treatment to delivery
Secondary outcomes:
measure: Prevalence of severe preeclampsia
timeFrame: From start of treatment to delivery
measure: Blood pressure
timeFrame: From start of treatment to delivery
measure: Proteinuria
timeFrame: From start of treatment to delivery
measure: Maternal complications
timeFrame: From start of treatment to delivery
measure: Fetal/neonatal status
timeFrame: From start of treatment to delivery
measure: Gestational age at delivery
timeFrame: At time of delivery
measure: Birth weight
timeFrame: At time of delivery
Other outcomes:
Locations:
city: Richmond
country: United States
facility: MCV Main Hospital
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Scott W Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Susan M Lanni, MD
role: STUDY_DIRECTOR
affiliation: Virginia Commonwealth University
name: Fidelma B Rigby, MD
role: STUDY_DIRECTOR
affiliation: Virginia Commonwealth University
name: Nicole W Karjane, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.