Myometrial Biopsy for the Detection of Infection
Not Applicable
- Conditions
- Infection
- Interventions
- Procedure: Biopsy
- Registration Number
- NCT00782665
- Lead Sponsor
- The Woman's Hospital of Texas
- 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 vagina being drawn up into the uterine cavity. During labor, bacterial colonization of the amniotic fluid, the decidua, and even the fetus can occur, resulting in infection of the mother and the fetus.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1000
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Biopsy Patients who have labored and subsequently delivered by cesarean section 2 Biopsy Patients who electively select cesarean section
- Primary Outcome Measures
Name Time Method Postoperative infection following rupture of amniotic membranes Amount of time it takes to obtain culture result
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Woman's Hospital of Texas
🇺🇸Houston, Texas, United States