Myometrial Biopsy for the Detection of Infection

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

Study Overview

• Status: Unknown
• Conditions: Infection
• Intervention / Treatment: Procedure: Biopsy

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • The Woman's Hospital of Texas
      • Contact: Donna Roth, BA; Phone Number: 713-791-7129; Email: Donna.Roth@HCAhealthcare.com
      • Principal Investigator: Sebastian Faro, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative infection following rupture of amniotic membranes	Amount of time it takes to obtain culture result

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 31, 2008

Study Record Updates

• Last Update Posted (Estimate): October 31, 2008
• Last Update Submitted That Met QC Criteria: October 28, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: infection; postoperative; c-section
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 10012008Faro