Clinical trial NCT04385680: Chlorhexidine Vaginal Preparation for Reduction of Post-cesarean Endometritis and Sepsis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postpartum Endometritis
Wound Infection
Chlorhexidine Adverse Reaction
Postoperative Fever
Keywords: post-cesarean endometritis
wound infection
chlorhexidine vaginal preparation
chlorhexidine adverse reaction
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-05-13
Enrollment: 840
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: post-cesarean endometritis
timeFrame: First 10 days post-cesarean
measure: Postoperative wound infection
timeFrame: First month after cesarean
Secondary outcomes:
measure: Significant leukocytosis
timeFrame: First 10 days postcesarean
measure: Chlorhexidine adverse drug reaction
timeFrame: First 10 days
measure: incidence of hospital readmission
timeFrame: One month
measure: length of hospital stay
timeFrame: One month
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: Armed Forces Hospitals Southern Region
Study officials:
affiliation: Armed forces hospitals Southern Region KSA
name: Ahmed Shafiek
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Hospitals Southern Region
name: Hytham Atia
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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(7):CD007892. doi: 10.1002/14651858.CD007892.pub6.