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Myometrial Biopsy for the Detection of Infection

Myometrial Biopsy for the Detection of Infection

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00782665
Enrollment
1000
Registered
2008-10-31
Start date
2008-07-31
Completion date
2010-07-31
Last updated
2008-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

postoperative, infection, c-section

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.

Interventions

PROCEDUREBiopsy

1 centimeter x 1/2 centimeter piece cut from uterus

Sponsors

The Woman's Hospital of Texas
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Postoperative infection following rupture of amniotic membranesAmount of time it takes to obtain culture result

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026