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

October 28, 2008
October 28, 2008
July 2008
June 2010   (final data collection date for primary outcome measure)
Postoperative infection following rupture of amniotic membranes [ Time Frame: Amount of time it takes to obtain culture result ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Myometrial Biopsy for the Detection of Infection
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.

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.

Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infection
Procedure: Biopsy
1 centimeter x 1/2 centimeter piece cut from uterus
  • Active Comparator: Group 1
    Patients who have labored and subsequently delivered by cesarean section
    Intervention: Procedure: Biopsy
  • Placebo Comparator: 2
    Patients who electively select cesarean section
    Intervention: Procedure: Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
July 2010
June 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 48 Years
Yes
Not Provided
United States
 
NCT00782665
10012008Faro
No
Sebastian Faro, MD, PhD, The Woman's Hospital of Texas
The Woman's Hospital of Texas
Not Provided
Principal Investigator: Sebastian Faro, MD, PhD The Woman's Hospital of Texas
The Woman's Hospital of Texas
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP