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Myometrial Biopsy for the Detection of Infection

NCT ID: NCT00782665

Last Updated: 2008-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infection

Keywords

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postoperative infection c-section

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Patients who have labored and subsequently delivered by cesarean section

Group Type ACTIVE_COMPARATOR

Biopsy

Intervention Type PROCEDURE

1 centimeter x 1/2 centimeter piece cut from uterus

2

Patients who electively select cesarean section

Group Type PLACEBO_COMPARATOR

Biopsy

Intervention Type PROCEDURE

1 centimeter x 1/2 centimeter piece cut from uterus

Interventions

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Biopsy

1 centimeter x 1/2 centimeter piece cut from uterus

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Woman's Hospital of Texas

OTHER

Sponsor Role lead

Responsible Party

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The Woman's Hospital of Texas

Principal Investigators

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Sebastian Faro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Woman's Hospital of Texas

Locations

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The Woman's Hospital of Texas

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Donna Roth, BA

Role: primary

Other Identifiers

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10012008Faro

Identifier Type: -

Identifier Source: org_study_id