Myometrial Biopsy for the Detection of Infection

• Sponsor: The Woman's Hospital of Texas (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00782665
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 41.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infection	Procedure: Biopsy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Myometrial Biopsy for the Detection of Infection
• Study Start Date: Jul 1, 2008
• Anticipated Primary Completion Date: Jun 1, 2010
• Anticipated Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Patients who have labored and subsequently delivered by cesarean section	Procedure: Biopsy; 1 centimeter x 1/2 centimeter piece cut from uterus
Placebo Comparator: 2 Patients who electively select cesarean section	Procedure: Biopsy; 1 centimeter x 1/2 centimeter piece cut from uterus

Outcome Measures

Primary Outcome Measures

1. Postoperative infection following rupture of amniotic membranes [Amount of time it takes to obtain culture result]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Woman's Hospital of Texas	Houston	Texas	United States	77054

Sponsors and Collaborators

• The Woman's Hospital of Texas

Investigators

• Principal Investigator: Sebastian Faro, MD, PhD, The Woman's Hospital of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00782665
• Other Study ID Numbers: 10012008Faro
• First Posted: Oct 31, 2008
• Last Update Posted: Oct 31, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: postoperative; infection; c-section
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

No Results Posted as of Oct 31, 2008