Chlorhexidine Adverse Reaction, Postoperative Fever, Postpartum Endometritis, Wound Infection
Conditions
Keywords
post-cesarean endometritis, wound infection, chlorhexidine vaginal preparation, chlorhexidine adverse reaction
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
Interventions
DRUGChlorhexidine Gluconate vaginal solution 0.05%
preoperative vaginal preparation
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-cesarean endometritis | First 10 days post-cesarean | 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 |
| Postoperative wound infection | First month after cesarean | erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant leukocytosis | First 10 days postcesarean | increase of WBCs count \> 50% from preoperative count |
| Chlorhexidine adverse drug reaction | First 10 days | maternal or neonatal allergy or irritation |
| incidence of hospital readmission | One month | percent of cases needed readmission in both arms |
| length of hospital stay | One month | duration of hospitalization due to endometritis |
Countries
Saudi Arabia
Outcome results
None listed