Myometrial Biopsy for the Detection of Infection

The Woman's Hospital of Texas1,000 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Infection

Interventions

BiopsyPROCEDURE

1 centimeter x 1/2 centimeter piece cut from uterus

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Woman's Hospital of Texas

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Postoperative infection following rupture of amniotic membranes

Time frame: Amount of time it takes to obtain culture result

Data from ClinicalTrials.gov

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