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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00386477
• Other study ID #: 0509-55 (Study #)
• Secondary ID: 0509-55
• Status: Terminated
• Phase: N/A
• First received: October 9, 2006
• Last updated: January 14, 2010
• Start date: September 2006
• Est. completion date: May 2009

Study information

• Verified date: December 2010
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.

Description:

Infectious morbidity frequently complicates cesarean delivery. Endometritis can complicate the postoperative course of a cesarean delivery 6-27% of the time. This complication, up to 10 times more frequent than after vaginal delivery, can lead to serious complications. Additionally, cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma, hematoma, infection, and separation. These morbidities can lead to significant delay in a return to normal function. Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups. The control group will receive the standard surgical preparation of the abdomen alone, the current standard pre-cesarean preparation. The other group will also receive a povidone iodine washing/scrub of the vagina before the cesarean delivery. Maternal and surgical variables will be recorded. At one months postpartum, maternal outpatient data will be reviewed and the incidence of postpartum uterine infection, wound separations, and other wound and infectious complications will be determined and compared between the two treatment groups.

Comparison: Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Woman undergoing cesarean delivery

• At least 18 years of age

Exclusion Criteria:

• Allergy to iodine containing solutions

• Planned cesarean hysterectomy

• Prisoner

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Section
• Communicable Diseases
• Endometritis
• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• Vaginal cleansing before cesarean delivery
Cleansing vagina with 1% betadine scrub before cesarean.

Locations

Country	Name	City	State
United States	Methodist Hospital	Indianapolis	Indiana
United States	University Hospital	Indianapolis	Indiana
United States	Wishard Memorial Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.		1 month	No