Myometrial Biopsy for the Detection of Infection

Infection Clinical Trial

Official title:

Myometrial Biopsy for the Detection of Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00782665
• Other study ID #: 10012008Faro
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2008
• Last updated: October 28, 2008
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2008
• Source: The Woman's Hospital of Texas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

1. Patients must be afebrile throughout labor.

2. Amniotic fluid must be not purulent; presence of meconium is not an exclusion.

3. Patients undergoing an elective cesarean section.

4. Patients who have labored with intact or ruptured amniotic membranes.

Exclusion Criteria:

1. Patient with a temperature of = 100.4o F.

2. White blood cell count = 24,000.

3. Suspicion of chorioamnionitis.

4. Suspicion of a urinary tract infection.

5. Presence of diarrhea (defined > 4 liquid stools in a 24 hour period).

6. Patient currently taking therapeutic antibiotics.

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Procedure:
• Biopsy
1 centimeter x 1/2 centimeter piece cut from uterus

Locations

Country	Name	City	State
United States	The Woman's Hospital of Texas	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Woman's Hospital of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative infection following rupture of amniotic membranes		Amount of time it takes to obtain culture result	No