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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385680
• Other study ID #: chlorhex. post cs endometritis
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 15, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: August 30, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Chlorhexidine Gluconate vaginal solution 0.05%
preoperative vaginal preparation

Locations

Country	Name	City	State
Saudi Arabia	Armed Forces Hospitals Southern Region	Khamis Mushait

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

Betrán AP, Ye J, Moller AB, Zhang J, Gülmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016. — View Citation

Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7:CD007892. doi: 10.1002/14651858.CD007892.pub6. Review. Update in: Cochrane Database Syst Rev. 2020 Apr 26;4:CD007892. — View Citation

Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Postoperative wound infection	erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.	First month after cesarean
Secondary	Significant leukocytosis	increase of WBCs count > 50% from preoperative count	First 10 days postcesarean
Secondary	Chlorhexidine adverse drug reaction	maternal or neonatal allergy or irritation	First 10 days
Secondary	incidence of hospital readmission	percent of cases needed readmission in both arms	One month
Secondary	length of hospital stay	duration of hospitalization due to endometritis	One month