NCT00371722

Brief Summary

Women having cesarean section will be divided into two groups - cesarean section alone or cesarean section with appendectomy. The purpose is to see if the appendectomy can be done without adding any complications to the maternal post-operative course. The hypothesis is that there is no increased incidence of wound infection, post-operative morbidity or longer hospital stay associated with elective appendectomy at the time of Cesarean Section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

August 31, 2006

Last Update Submit

April 19, 2007

Conditions

Cesarean DeliveryAppendectomy

Keywords

Cesarean sectionAppendectomy

Outcome Measures

Primary Outcomes (1)

  • Post-operative wound infection

Secondary Outcomes (3)

  • Post-operative fever

  • Post-operative length of hospital stay

  • Post-operative need for pain control

Interventions

AppendectomyPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years age
  • No previous appendectomy
  • Adequate pain control for cesarean section
  • Able to give informed consent

You may not qualify if:

  • Previous appendectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Interventions

Appendectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Charles D Adair, MD

    Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

July 1, 2002

Study Completion

May 1, 2006

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

US(1)