We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myometrial Biopsy for the Detection of Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00782665
Recruitment Status : Unknown
Verified October 2008 by The Woman's Hospital of Texas.
Recruitment status was:  Recruiting
First Posted : October 31, 2008
Last Update Posted : October 31, 2008
Sponsor:
Information provided by:
The Woman's Hospital of Texas

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
Infection 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  (Clinical Trial)
Estimated 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 : July 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Postoperative infection following rupture of amniotic membranes [ Time Frame: Amount of time it takes to obtain culture result ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sebastian Faro, MD, PhD, The Woman's Hospital of Texas
ClinicalTrials.gov Identifier: NCT00782665     History of Changes
Other Study ID Numbers: 10012008Faro
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

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

Additional relevant MeSH terms:
Infection
Communicable Diseases