Myometrial Biopsy for the Detection of Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by The Woman's Hospital of Texas.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Woman's Hospital of Texas
ClinicalTrials.gov Identifier:
NCT00782665
First received: October 28, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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


Condition Intervention
Infection
Procedure: Biopsy

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Myometrial Biopsy for the Detection of Infection

Resource links provided by NLM:


Further study details as provided by The Woman's Hospital of Texas:

Primary Outcome Measures:
  • Postoperative infection following rupture of amniotic membranes [ Time Frame: Amount of time it takes to obtain culture result ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782665

Locations
United States, Texas
The Woman's Hospital of Texas Recruiting
Houston, Texas, United States, 77054
Contact: Donna Roth, BA    713-791-7129    Donna.Roth@HCAhealthcare.com   
Principal Investigator: Sebastian Faro, MD, PhD         
Sponsors and Collaborators
The Woman's Hospital of Texas
Investigators
Principal Investigator: Sebastian Faro, MD, PhD The Woman's Hospital of Texas
  More Information

No publications provided

Responsible Party: Sebastian Faro, MD, PhD, The Woman's Hospital of Texas
ClinicalTrials.gov Identifier: NCT00782665     History of Changes
Other Study ID Numbers: 10012008Faro
Study First Received: October 28, 2008
Last Updated: October 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Woman's Hospital of Texas:
postoperative
infection
c-section

ClinicalTrials.gov processed this record on August 27, 2014