Trial Outcomes & Findings for Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial (NCT NCT00386477)

NCT ID: NCT00386477

Last Updated: 2010-02-08

Results Overview

Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2010-02-08

Participant Flow

Participant milestones

Measure	Vag Prep Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean	Control No vaginal cleansing or sham wash performed.
Overall Study STARTED	155	145
Overall Study COMPLETED	155	145
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Vag Prep n=155 Participants Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean	Control n=145 Participants No vaginal cleansing or sham wash performed.	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	155 Participants n=5 Participants	145 Participants n=7 Participants	300 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	26.8 years STANDARD_DEVIATION 5.9 • n=5 Participants	26.6 years STANDARD_DEVIATION 5.7 • n=7 Participants	26.7 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	145 Participants n=7 Participants	300 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized	155 participants n=5 Participants	145 participants n=7 Participants	300 participants n=5 Participants
Region of Enrollment United States	155 participants n=5 Participants	145 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Randomization

Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.

Outcome measures

Measure	Vag Prep n=155 Participants Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean	Control n=145 Participants No vaginal cleansing or sham wash performed.
Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.	10 participants	17 participants

Adverse Events

Vag Prep

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David M. Haas, MD, MS

Indiana University School of Medicine

Phone: 317-630-7837

Email: dahaas@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place