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

Zagazig University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chlorhexidine Adverse Reaction; Postpartum Endometritis; Postoperative Fever; Wound Infection

Treatments: Drug: Chlorhexidine Gluconate vaginal solution 0.05%

Study type: Interventional

Funder types: Other

Identifiers

NCT04385680

chlorhex. post cs endometritis

Details and patient eligibility

About

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.

Full 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

Enrollment: 840 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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840 participants in 2 patient groups

Chlorhexidine vaginal prep.arm

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine Gluconate vaginal solution 0.05%

No vaginal antiseptic arm

No Intervention group

Description:

Women in labor who will receive abdominal scrub with chlorhexidine gluconate 4% only. Vaginal preparation is not including antiseptic or using normal saline only.