跳至主要内容
临床试验/2022-501930-49-00
2022-501930-49-00已完成4 期

Oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear - a double-blinded placebo controlled randomized trail

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 442 人开始时间: 2023年2月2日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
442
试验地点
1
主要终点
Number of women with perineal infection or wound dehiscence

研究概览

简要总结

To investigate wheather three doses of oral antibiotics given to women with an obstetric perineal wound can reduce the risk of infection and wound dehiscence compared to placebo treatment

入排标准

年龄范围
18 years 至 64 years(18-64 Years)
性别
Female
接受健康志愿者

入选标准

  • Women with a second degree tear or an episiotomy of the perineum after a vaginal delivery
  • Women above 18 year
  • Women wh speaks and read Danish
  • Women who are mentally capable of giving informed consent at time of inclusion
  • Tear being sutured at Herlev Hospital

排除标准

  • Women with allergies towards the used drug
  • Women who ends in Caesarean section even though she has a vaginal tear og episiotomy
  • Women that for any other reasons recieve antbiotics during or after labour

结局指标

主要结局

Number of women with perineal infection or wound dehiscence

Number of women with perineal infection or wound dehiscence

次要结局

  • Number of women with complications after one week and one year. Complications being investigated: incontinence, pelvic prolaps, pain, sexsual dysfunktions

研究者

申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Hanna Jangö

Scientific

Herlev Hospital

研究点 (1)

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