Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Wound infection (surgical site infection SSI)
研究概览
简要总结
To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.
详细描述
All patients (interventions and control group) are informed not to practice coitus, or use any vaginal products (such as douches, tampons or any type of pessary) during the period of intervention. Also, no vaginal examination was performed to all participants within 3 days of the CS.
The circulating nurse will clean the skin to all participants by following the manufacturer's guidelines.
The antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin.
The skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances.
All the enrolled participants receive the same health education and wound care advice from the professional health team.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female participants with singleton pregnancies scheduled for elective cesarean sections at term, specifically between 37 and 40 weeks of gestation
- •free from any medical disorders.
- •The participants' ages ranged from 18 to 40 years
- •body mass index (BMI) ranged from 18 to 30 kg/m2
排除标准
- •Cases of urgent or emergent CS.
- •Abnormal vaginal secretion (bad smelling yellowish secretion, whitish cheesy discharge with pruritus, bloody discharge; etc…).
- •Women with medical disorders such as pre-gestational diabetes, anemia, hypertension, preeclampsia, or immunosuppressant pregnant women.
- •Women who had a skin infection adjacent to the operative site.
- •Allergy to topical povidone-iodine or clindamycin
- •Feverish patients or history of premature rupture of membranes or with placenta previa.
- •patients lost during follow-up were excluded from the final analysis.
研究组 & 干预措施
control
the control group has only prophylactic antibiotics according to hospital protocols.
Clindamycin vaginal cream
Clindamycin vaginal cream one applicator each night for 3 nights before CS.
干预措施: Clindamycin vaginal cream (Drug)
Vaginal preparation with povidone- iodide solution 10 %
Vaginal preparation with povidone- iodide solution 10 % before skin incision with sponge sticks prior to caesarean section.
干预措施: Vaginal preparation with povidone- iodide solution 10 % (Drug)
结局指标
主要结局
Wound infection (surgical site infection SSI)
时间窗: 3 weeks
erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site.
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
Associate Professor of obstetrics and gynecology
Beni-Suef University