Myometrial Biopsy for the Detection of Infection

The Woman's Hospital of Texas

Status: Unknown

Conditions: Infection

Treatments: Procedure: Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT00782665

10012008Faro

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

Patients who have labored and subsequently delivered by cesarean section

Treatment:

Procedure: Biopsy

2

Placebo Comparator group

Description:

Patients who electively select cesarean section

Treatment:

Procedure: Biopsy