Status:
UNKNOWN
Myometrial Biopsy for the Detection of Infection
Lead Sponsor:
The Woman's Hospital of Texas
Conditions:
Infection
Eligibility:
FEMALE
18-48 years
Phase:
NA
Brief Summary
This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.
Detailed Description
The infection is a dynamic process probably beginning shortly after the onset of labor. This process continues and is enhanced during active uterine contractions, which result in bacteria from the vag...
Eligibility Criteria
Inclusion
- Patients must be afebrile throughout labor.
- Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
- Patients undergoing an elective cesarean section.
- Patients who have labored with intact or ruptured amniotic membranes.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00782665
Start Date
July 1 2008
End Date
July 1 2010
Last Update
October 31 2008
Active Locations (1)
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1
The Woman's Hospital of Texas
Houston, Texas, United States, 77054