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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cesarean Section, Endometritis, Surgical Wound Infection

Intervention / Treatment
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* Procedure: Vaginal cleansing before cesarean delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman undergoing cesarean delivery At least 18 years of age Exclusion Criteria: Allergy to iodine containing solutions Planned cesarean hysterectomy Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vag prep<br>Vagina cleansed prior to performing cesarean | Procedure: Vaginal cleansing before cesarean delivery<br>* Cleansing vagina with 1% betadine scrub before cesarean.<br>* Other names: 1% betadine scrub of vagina with vaginal scrub spongesticks.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. | Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Povidone iodine, postoperative infection, presurgical cleansing