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临床试验/NCT07053995
NCT07053995已完成不适用

EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY

Khyber Teaching Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Endometrial Infection

研究概览

简要总结

After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14.

详细描述

After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution as single push where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14. Data was recorded and analyzed.

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 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women between 18-40 years
  • •Gestational age greater than 36 weeks undergoing elective C section

排除标准

  • •Pregnant women with history of allergic reactions to chlorhexidine
  • •Placenta previa on ultrasound scan
  • •Diabetes Mellitus on fasting blood sugar
  • •Anemia (Hb less than 7g/dl)

研究组 & 干预措施

Participants with vaginal cleaning

Experimental

Total of 38 participants included randomly after informed consent. Vaginal cleaning with 50cc (0.5cc chlorhexidine) along with abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded.

干预措施: Vaginal cleaning (Procedure)

Participants with non vaginal cleansing

Other

Total of 38 participants included randomly after informed consent. Only routine abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded.

干预措施: Non vaginal cleansing (Other)

结局指标

主要结局

Endometrial Infection

时间窗: 14 days

Body temperature was measured postoperatively along with any dicharge of pain around uterine region 24hrs after surgery

Surgical site infection

时间窗: 14 days

Incision site was inspected on 4th and 14th post operative day and documented any evidence of infection signs according to Southampton wound grading system.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naba Rehman

Consultant

Khyber Teaching Hospital

研究点 (1)

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