Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- Infectious morbidities
研究概览
简要总结
Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Endometritis accounts for 6-27% followed by clinically significant fever, which was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous studies evaluated whether vaginal cleansing can reduce the incidence of postoperative infectious morbidity. In most of the studies, povidone iodine was used as intervention.
Objectives: The aim of this study is to test the hypothesis that preoperative vaginal cleansing with chlorhexidine would be superior to iodine for the prevention of maternal infectious morbidities including endometritis, fever and wound complications.
Methods: This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed within 30 days of C-section.
详细描述
This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. All pregnant women who will undergo cesarean delivery and willing to sign the informed consent will be included. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed d within 30 days of C-section.
Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains either chlorhexidine or iodine, sponge will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 sec. All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin within 30 minutes prior to the incision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •all pregnant women who will undergo cesarean delivery
- •and willing to sign the informed consent.
排除标准
- •Known allergy to the antiseptics used
- •Infection diagnosis on admission
- •Age ≤ 17 years
研究组 & 干预措施
Group chlorhexidine
Patients will receive chlorhexidine abdominal and vaginal scrubbing
干预措施: Chlorhexidine (Other)
Group iodine
Patients will receive iodine abdominal and vaginal scrubbing
干预措施: Iodine (Other)
Group chlorhexidine
Patients will receive chlorhexidine abdominal and vaginal scrubbing
干预措施: Antibiotics (Other)
Group iodine
Patients will receive iodine abdominal and vaginal scrubbing
干预措施: Antibiotics (Other)
结局指标
主要结局
Infectious morbidities
时间窗: Within 30 days
post cesarean infectious morbidities: endometritis, febrile morbidity and wound infection
次要结局
- Readmission to the hospital(Within 30 days)
- Length of hospital stay(Within 30 days)
研究者
Manal Hubeish
OBGYN attending physician
Makassed General Hospital