Back to resultsMyometrial Biopsy for the Detection of Infection
Primary Purpose
Infection
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring postoperative, infection, c-section
Eligibility Criteria
Inclusion Criteria:
- Patients must be afebrile throughout labor.
- Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
- Patients undergoing an elective cesarean section.
- Patients who have labored with intact or ruptured amniotic membranes.
Exclusion Criteria:
- Patient with a temperature of ≥ 100.4o F.
- White blood cell count ≥ 24,000.
- Suspicion of chorioamnionitis.
- Suspicion of a urinary tract infection.
- Presence of diarrhea (defined > 4 liquid stools in a 24 hour period).
- Patient currently taking therapeutic antibiotics.
Sites / Locations
- The Woman's Hospital of TexasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1
2
Arm Description
Patients who have labored and subsequently delivered by cesarean section
Patients who electively select cesarean section
Outcomes
Primary Outcome Measures
Postoperative infection following rupture of amniotic membranes
Secondary Outcome Measures
Full Information
NCT ID
NCT00782665
First Posted
October 28, 2008
Last Updated
October 28, 2008
Sponsor
The Woman's Hospital of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00782665
Brief Title
Myometrial Biopsy for the Detection of Infection
Official Title
Myometrial Biopsy for the Detection of Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Woman's Hospital of Texas
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
postoperative, infection, c-section
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Patients who have labored and subsequently delivered by cesarean section
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients who electively select cesarean section
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
1 centimeter x 1/2 centimeter piece cut from uterus
Primary Outcome Measure Information:
Title
Postoperative infection following rupture of amniotic membranes
Time Frame
Amount of time it takes to obtain culture result
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients must be afebrile throughout labor.
Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
Patients undergoing an elective cesarean section.
Patients who have labored with intact or ruptured amniotic membranes.
Exclusion Criteria:
Patient with a temperature of ≥ 100.4o F.
White blood cell count ≥ 24,000.
Suspicion of chorioamnionitis.
Suspicion of a urinary tract infection.
Presence of diarrhea (defined > 4 liquid stools in a 24 hour period).
Patient currently taking therapeutic antibiotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Faro, MD, PhD
Organizational Affiliation
The Woman's Hospital of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Woman's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Roth, BA
Phone
713-791-7129
Email
Donna.Roth@HCAhealthcare.com
First Name & Middle Initial & Last Name & Degree
Sebastian Faro, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Myometrial Biopsy for the Detection of Infection
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