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

Phase 1

Completed

• Conditions: Postoperative Fever; Postpartum Endometritis; Chlorhexidine Adverse Reaction; Wound Infection
• Interventions: Drug: Chlorhexidine Gluconate vaginal solution 0.05%

• Registration Number: NCT04385680
• Lead Sponsor: Zagazig University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-05-15
• Primary Completion: 2022-03-10
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 840

Inclusion Criteria

1. Gestational age ≥28 weeks.
2. Cases had cesarean section after start of labor.

Exclusion Criteria

1. Women with known allergy to chlorhexidine gluconate or any of its ingredients.
2. Women with diagnosed group B streptococcus (GBS) colonization.
3. Women with active infection during the procedure.
4. Women did not receive the standard preoperative antibiotic prophylaxis.
5. Women with diagnosis of chorioamnionitis.
6. Prolonged rupture of membranes >7 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine vaginal prep.arm	Chlorhexidine Gluconate vaginal solution 0.05%	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.

Primary Outcome Measures

Name	Time	Method
post-cesarean endometritis	First 10 days post-cesarean	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
Postoperative wound infection	First month after cesarean	erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Armed Forces Hospitals Southern Region; 🇸🇦 Khamis Mushait, Saudi Arabia