Chlorhexidine Vaginal Preparation for Reduction of Post-cesarean Endometritis and Sepsis

Study Overview
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Brief Summary
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The study aims to assess the beneficial value of vaginal preparation with chlorhexidine gluconate 0.05% before cesarean delivery of cases in labor in reduction of postoperative endometritis, fever and wound complications compared to no preparation or using saline only.

Detailed Description
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Despite the demonstrated effectiveness of the vaginal cleansing in the previous study, yet this has not been adopted within obstetric practice internationally and does not feature within the NICE Intrapartum guideline.7 This is may be due to concerns with exposure of the fetus to iodine-based substances, concerns with vaginal staining and allergy to iodine. Iodine is an antibacterial agent, but becomes inactive by the presence of blood may limit its use. Chlorhexidine show greater reduction in skin flora after application compared with povidone-iodine agents (0.5 and 4%) respectively and has a greater residual activity after application than other preparations and (unlike povidone iodine) it is not inactivated by the presence of blood. Thus, there are a number of reasons to believe that vaginal cleansing with chlorhexidine would be an appropriate alternative to povidone iodine.8 There is one RCT comparing povidone iodine with chlorhexidine gluconate for vaginal cleansing at CS. This suggested that chlorhexidine may be superior, and further research was needed.9 Solutions that contain lower concentrations, such as chlorhexidine gluconate and acetate (0.05%) are usually well tolerated and may be used for vaginal preparation. With this preparation, there are no reported cases of allergy.8 Importantly, no safety concerns for the mother or baby have been identified with chlorhexidine gluconate used for vaginal cleansing.10

Official Title
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The Impact of Chlorhexidine Preoperative Vaginal Preparation in Reducing the Post-cesarean Endometritis and Sepsis for Cases in Labor. A Randomized Controlled Trial

Conditions
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Postpartum Endometritis, Wound Infection, Chlorhexidine Adverse Reaction, Postoperative Fever

Intervention / Treatment
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* Drug: Chlorhexidine Gluconate vaginal solution 0.05%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age ≥28 weeks. Cases had cesarean section after start of labor. Exclusion Criteria: Women with known allergy to chlorhexidine gluconate or any of its ingredients. Women with diagnosed group B streptococcus (GBS) colonization. Women with active infection during the procedure. Women did not receive the standard preoperative antibiotic prophylaxis. Women with diagnosis of chorioamnionitis. Prolonged rupture of membranes >7 days

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: Chlorhexidine vaginal prep.arm<br>Women in labor who will receive vaginal cleaning immediately before cesarean section using 50 ml of chlorhexidine gluconate 0.05% solution and standard abdominal scrub with chlorhexidine gluconate 4%. This concentration is indicated within the British National Formulary for swabbing in obstetrics. A swab soaked in the antiseptic will be used to clean the vagina for 30 seconds prior to CS at the time of urinary catheter insertion by long forceps. After the CS procedure, the vagina is always cleaned of excess blood as with a dry swab. | Drug: Chlorhexidine Gluconate vaginal solution 0.05%<br>* preoperative vaginal preparation<br>* Other names: No preparation or preparation with saline only;|
| No Intervention: No vaginal antiseptic arm<br>Women in labor who will receive abdominal scrub with chlorhexidine gluconate 4% only. Vaginal preparation is not including antiseptic or using normal saline only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-cesarean endometritis | uterine fundal tenderness on bimanual examination ( physical examination: suprapubic tenderness, pain elicited by cervical motion, tenderness in parametrium, all during bimanual examination) + with fever (An oral temperature of 38°C or higher within the first 10 days postpartum or 38.7°C within the first 24 hours postpartum) ± purulent lochia requiring antibiotic therapy ( initial antibiotic will be started then waiting for proper therapy according to culture and sensitivity | First 10 days post-cesarean | 
| Postoperative wound infection | erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy. | First month after cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant leukocytosis | increase of WBCs count > 50% from preoperative count | First 10 days postcesarean | 
| Chlorhexidine adverse drug reaction | maternal or neonatal allergy or irritation | First 10 days | 
| incidence of hospital readmission | percent of cases needed readmission in both arms | One month | 
| length of hospital stay | duration of hospitalization due to endometritis | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-cesarean endometritis, wound infection, chlorhexidine vaginal preparation, chlorhexidine adverse reaction