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

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.

Study Overview

• Status: Withdrawn
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Celecoxib; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • MCV Main Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; Gelatin capsules of lactose
Experimental: 1; Celecoxib, 200 mg/day	Drug: Celecoxib; Capsule, 200 mg/day until 32 weeks of gestation; Other Names: Celebrex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Scott W Walsh, PhD, Virginia Commonwealth University; Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 28, 2007
• First Submitted That Met QC Criteria: February 28, 2007
• First Posted (Estimate): March 2, 2007

Study Record Updates

• Last Update Posted (Estimate): March 13, 2012
• Last Update Submitted That Met QC Criteria: March 12, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: VCU IRB HM10590