Myometrial Biopsy for the Detection of Infection | NCT00782665

Studies
Myometrial Biopsy for the Detection of Infection

NCT00782665

Sponsor

The Woman's Hospital of Texas

Status

Unknown status

Last Update Posted

Oct 31, 2008Estimated

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Infection

Interventions

Biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jun 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

Oct 28, 2008

First Submission Date that Met QC Criteria

Oct 28, 2008

First Posted Date

Oct 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2008

Last Update Posted Date

Oct 31, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Patients who have labored and subsequently delivered by cesarean section	Procedure: Biopsy
2	Placebo Comparator	Patients who electively select cesarean section	Procedure: Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biopsy	Procedure	1 centimeter x 1/2 centimeter piece cut from uterus	2 Group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian Faro, MD, PhD	The Woman's Hospital of Texas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Woman's Hospital of Texas	Recruiting	Houston	Texas	77054	United States

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided