NCT00782665

Brief Summary

This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

1.9 years

First QC Date

October 28, 2008

Last Update Submit

October 28, 2008

Conditions

Infection

Keywords

postoperativeinfectionc-section

Outcome Measures

Primary Outcomes (1)

  • Postoperative infection following rupture of amniotic membranes

    Amount of time it takes to obtain culture result

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patients who have labored and subsequently delivered by cesarean section

Procedure: Biopsy

2

PLACEBO COMPARATOR

Patients who electively select cesarean section

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

1 centimeter x 1/2 centimeter piece cut from uterus

2Group 1

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must be afebrile throughout labor.
  • Patients undergoing an elective cesarean section.
  • Patients who have labored with intact or ruptured amniotic membranes.

You may not qualify if:

  • Patient with a temperature of ≥ 100.4o F.
  • White blood cell count ≥ 24,000.
  • Suspicion of chorioamnionitis.
  • Suspicion of a urinary tract infection.
  • Presence of diarrhea (defined \> 4 liquid stools in a 24 hour period).
  • Patient currently taking therapeutic antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Woman's Hospital of Texas

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sebastian Faro, MD, PhD

    The Woman's Hospital of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 31, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

US(1)