NCT00442676

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

February 28, 2007

Last Update Submit

March 12, 2012

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Length from start of treatment to delivery

    From start of treatment to delivery

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Celecoxib, 200 mg/day

Drug: Celecoxib

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CelecoxibDRUG

Capsule, 200 mg/day until 32 weeks of gestation

Also known as: Celebrex
1
PlaceboDRUG

Gelatin capsules of lactose

2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MCV Main Hospital

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

  • 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.

    PMID: 17240230BACKGROUND

  • 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.

    PMID: 15148293BACKGROUND

  • 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.

    PMID: 15924527BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 2, 2007

Study Start

June 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

US(1)