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

Indiana University School of Medicine

Status: Terminated

Conditions: Cesarean Section; Endometritis; Surgical Wound Infection

Treatments: Procedure: Vaginal cleansing before cesarean delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT00386477

0509-55 (Study #)

0509-55 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Woman undergoing cesarean delivery
• At least 18 years of age

Exclusion criteria

• Allergy to iodine containing solutions
• Planned cesarean hysterectomy
• Prisoner

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 1 patient group

Vag prep

Experimental group

Description:

Vagina cleansed prior to performing cesarean

Treatment:

Procedure: Vaginal cleansing before cesarean delivery