Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection

Study Overview
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Brief Summary
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Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Endometritis accounts for 6-27% followed by clinically significant fever, which was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous studies evaluated whether vaginal cleansing can reduce the incidence of postoperative infectious morbidity. In most of the studies, povidone iodine was used as intervention. Objectives: The aim of this study is to test the hypothesis that preoperative vaginal cleansing with chlorhexidine would be superior to iodine for the prevention of maternal infectious morbidities including endometritis, fever and wound complications. Methods: This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed within 30 days of C-section.

Detailed Description
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This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. All pregnant women who will undergo cesarean delivery and willing to sign the informed consent will be included. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed d within 30 days of C-section. Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains either chlorhexidine or iodine, sponge will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 sec. All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin within 30 minutes prior to the incision.

Official Title
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Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection: Randomized Clinical Trial

Conditions
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Vaginal Scrubbing

Intervention / Treatment
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* Other: Chlorhexidine
* Other: Iodine
* Other: Antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all pregnant women who will undergo cesarean delivery and willing to sign the informed consent. Exclusion Criteria: Known allergy to the antiseptics used Infection diagnosis on admission Age ≤ 17 years

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group chlorhexidine<br>Patients will receive chlorhexidine abdominal and vaginal scrubbing | Other: Chlorhexidine<br>* Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains chlorhexidine. A sponge soaked with chlorhexidine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds<br>Other: Antibiotics<br>* All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.<br>|
| Active Comparator: Group iodine<br>Patients will receive iodine abdominal and vaginal scrubbing | Other: Iodine<br>* Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains iodine. A sponge soaked with iodine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds<br>Other: Antibiotics<br>* All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious morbidities | post cesarean infectious morbidities: endometritis, febrile morbidity and wound infection | Within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of hospital stay after delivery | Within 30 days | 
| Readmission to the hospital | Percentage of patients readmitted to the hospital | Within 30 days |