Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery

Study Overview
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Brief Summary
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Endometritis, an infection of the uterus in the postpartum period, has been shown to complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal cleansing prior to cesarean delivery has been shown to minimize the presence of micro-organisms and risk of infection. Although povidone-iodine is the most commonly used anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine gluconate, on the other hand, has demonstrated superior disinfectant properties in several clinical trials, as compared to povidone iodine. In this randomized, comparator controlled, study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.

Detailed Description
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This is a randomized, comparator controlled, study of intrapartum vaginal preparation with either chlorhexidine gluconate or povidone-iodine solution. Women undergoing non-emergent cesarean delivery will be randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% providone-iodine solution. The study will have two arms that will be randomized in a 1:1 ratio. After inclusion criteria have been satisfied, subjects in the comparator control arm will receive vaginal preparation with 10% provodone-iodine solution prior the skin incision. Subjects in the study arm will receive vaginal preparation with chlorohexidine gluconate 4% solution. The selected skin preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. A block randomization method will be used to control for variations in care. Both groups will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.

Official Title
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Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery: A Randomized Comparator Controlled Trial

Conditions
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Wound Infection, Complication, Postoperative

Intervention / Treatment
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* Procedure: Povidone Iodine
* Procedure: Chlorhexidine gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at Richmond University Medical Center that have a non-emergent cesarean delivery Exclusion Criteria: Emergent cesarean delivery, less than 18 years of age, chorioamnionitis before randomization, intrapartum fever prior to randomization, or known or suspected allergy to chlorhexidine or iodine.

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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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Povidone Iodine<br>10% povidone iodine solution will be used for vaginal cleansing prior to non-emergent cesarean section. The preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. The group will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision. | Procedure: Povidone Iodine<br>* Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.<br>|
| Active Comparator: Chlorhexidine gluconate<br>4% chlorhexidine gluconate solution will be used for vaginal cleansing prior to non-emergent cesarean section. The preparation will be applied according to manufacture guidelines. The group will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision. | Procedure: Chlorhexidine gluconate<br>* Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative wound infection | Erythema surrounding the incision site or pus-like incisional drainage in the presence or absence of fever | 0-14 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum endometritis | Clinical diagnosis with temperature of 100.4 degrees F or higher occurring 24 hours after surgery with uterine fundal tenderness or purulent lochia. | 0-14 days post-partum | 
| Postoperative fever | Temperature greater than 38 degrees C or 100.4 degrees F | 0-14 days post-partum | 
| Side effects | Patient reported side effects of vaginal preparation (allergy, irritation) | 0-14 days post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean section, Chlorhexidine gluconate