NCT04385680

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Postpartum Endometritis
• Wound Infection
• Chlorhexidine Adverse Reaction
• Postoperative Fever

Interventions

Type	Name	Description
DRUG	Chlorhexidine Gluconate vaginal solution 0.05%	preoperative vaginal preparation

Timeline

• Start date: 2020-05-15
• Primary completion: 2022-03-10
• Completion: 2022-08-30
• First posted: 2020-05-13
• Last updated: 2022-09-23

Locations

1 site across 1 country: Saudi Arabia