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
Recruitment status was Recruiting
Sponsor:
The Woman's Hospital of Texas
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 28, 2008 | ||||
| Last Updated Date | October 28, 2008 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Postoperative infection following rupture of amniotic membranes [ Time Frame: Amount of time it takes to obtain culture result ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Myometrial Biopsy for the Detection of Infection | ||||
| Official Title ICMJE | Myometrial Biopsy for the Detection of Infection | ||||
| Brief Summary | This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Infection | ||||
| Intervention ICMJE | Procedure: Biopsy
1 centimeter x 1/2 centimeter piece cut from uterus |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | July 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 48 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00782665 | ||||
| Other Study ID Numbers ICMJE | 10012008Faro | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sebastian Faro, MD, PhD, The Woman's Hospital of Texas | ||||
| Study Sponsor ICMJE | The Woman's Hospital of Texas | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Woman's Hospital of Texas | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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