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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Fever; Wound Infection; Postpartum Endometritis; Chlorhexidine Adverse Reaction
• Intervention / Treatment: Drug: Chlorhexidine Gluconate vaginal solution 0.05%

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 Type: Interventional
• Enrollment (Actual): 840
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Saudi Arabia
  • Khamis Mushait, Saudi Arabia, 62411
    • Armed Forces Hospitals Southern Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chlorhexidine vaginal prep.arm; 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%; preoperative vaginal preparation; Other Names: No preparation or preparation with saline only
NO_INTERVENTION: No vaginal antiseptic arm; 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?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Ahmed Shafiek, Armed forces hospitals Southern Region KSA; Principal Investigator: Hytham Atia, Armed Forces Hospitals Southern Region

Publications and helpful links

General Publications

• Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu 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.
• 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(7):CD007892. doi: 10.1002/14651858.CD007892.pub6.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2020
• Primary Completion (ACTUAL): March 10, 2022
• Study Completion (ACTUAL): August 30, 2022

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (ACTUAL): May 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: wound infection; post-cesarean endometritis; chlorhexidine vaginal preparation; chlorhexidine adverse reaction
• Additional Relevant MeSH Terms: Infections; Uterine Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Wound Infection; Endometritis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: chlorhex. post cs endometritis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No