Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

This study has been terminated.

( Difficulty recruiting )

Study NCT00386477 Information provided by Indiana University

First Received on October 9, 2006. Last Updated on January 14, 2010 History of Changes

Results First Received: November 11, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Cesarean Section Endometritis Surgical Wound Infection
Intervention:	Procedure: Vaginal cleansing before cesarean delivery

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Vag Prep	Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
Control	No vaginal cleansing or sham wash performed.

Participant Flow: Overall Study

	Vag Prep	Control
STARTED	155	145
COMPLETED	155	145
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Vag Prep	Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
Control	No vaginal cleansing or sham wash performed.

Baseline Measures

	Vag Prep	Control	Total
Number of Participants [units: participants]	155	145	300
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	155	145	300
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	26.8 ± 5.9	26.6 ± 5.7	26.7 ± 5.8
Gender [units: participants]
Female	155	145	300
Male	0	0	0
Race/Ethnicity, Customized ^[1] [units: participants]	155	145	300
Region of Enrollment [units: participants]
United States	155	145	300

[1]	African-American Caucasian Hispanic Other

Outcome Measures

1. Primary:

Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. [ Time Frame: 1 month ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped before the planned enrollment of 1000 due to difficulty recruiting. Results are of a planned safety analysis at 300 subjects.

Results Point of Contact:

Name/Title: David M. Haas, MD, MS
Organization: Indiana University School of Medicine
phone: 317-630-7837
e-mail: dahaas@iupui.edu

No publications provided by Indiana University

Publications automatically indexed to this study:

Haas DM, Pazouki F, Smith RR, Fry AM, Podzielinski I, Al-Darei SM, Golichowski AM. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010 Mar;202(3):310.e1-6.

Responsible Party:	David M. Haas/ Assistant Professor of OB/GYN, Indiana University School of Medicine
ClinicalTrials.gov Identifier:	NCT00386477 History of Changes
Other Study ID Numbers:	0509-55 (Study #), 0509-55
Study First Received:	October 9, 2006
Results First Received:	November 11, 2009
Last Updated:	January 14, 2010
Health Authority:	United States: Institutional Review Board