The Impact of Chlorhexidine Preoperative Vaginal Preparation in Reducing the Post-cesarean Endometritis and Sepsis for Cases in Labor. A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- post-cesarean endometritis
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥28 weeks.
- •Cases had cesarean section after start of labor.
排除标准
- •Women with known allergy to chlorhexidine gluconate or any of its ingredients.
- •Women with diagnosed group B streptococcus (GBS) colonization.
- •Women with active infection during the procedure.
- •Women did not receive the standard preoperative antibiotic prophylaxis.
- •Women with diagnosis of chorioamnionitis.
- •Prolonged rupture of membranes >7 days
研究组 & 干预措施
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.
干预措施: Chlorhexidine Gluconate vaginal solution 0.05% (Drug)
结局指标
主要结局
post-cesarean endometritis
时间窗: 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
时间窗: First month after cesarean
erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.
次要结局
- Chlorhexidine adverse drug reaction(First 10 days)
- incidence of hospital readmission(One month)
- Significant leukocytosis(First 10 days postcesarean)
- length of hospital stay(One month)
研究者
Hytham Atia
Associate Professor Obstetrics & Gynecology
Zagazig University