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临床试验/NCT02072798
NCT02072798已完成4 期

Antibiotic Prophylaxis for Postpartum Infections Following Caesarean Section

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Maternal: incidence of post-CS infection (endometritis, urinary tract infections and wound infection) in each study group

研究概览

简要总结

Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS infections is 7-10%. The most common infections are endometritis, Urinary tract infections (UTI) and wound infections (WI).

Prophylactic antibiotics are effective in preventing postoperative infections and national guidelines recommend that antibiotics should be administered as a single dose immediately before surgical incision. CS is an exception to this pre-incision administration approach. National guidelines recommend administration of antibiotics after umbilical cord clamping to avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic prophylaxis for CS suggest that prophylactic antibiotics administered before incision compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on the baby and on late infection in the mother.

At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation of the digestive and immune functions to avoid gut disorders and infections. Full-term, breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene levels, antibiotics treatment and formula feeding may inhibit immune development both short and long term. Birth by caesarean section in high-hygiene hospital environments, and widespread use of antibiotics, are factors that reduce gut microbiota density and diversity in the newborn for some time after birth. On the other hand, high-hygiene environments and antibiotics are essential tools to combat infections, especially for the weakest newborn infants.

This pilot study will be a feasibility study to the original study, which examines the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut microbiota of newborn infants. The feasibility study will only include pregnant women in Odense with a body mass index below 30, and planned cesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 18 year
  • Women, who can read and understand Danish
  • A gestational age ≥ completed 28 weeks of gestation
  • Rupture of membranes and active labour (uterine contractions) is allowed.
  • BMI < 30

排除标准

  • Hypersensitivity to cefuroxime or to any other cephalosporin antibiotics
  • Previous immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic.
  • Systemic exposure to any antibiotic agent within 1 week before delivery Antibiotic indicated due to PROM, fever, group B Streptococcus or other indications at the time of caesarean section.
  • Women being immunologically incompetent (e.g. HIV positive)
  • Very sick newborn infants transferred to a neonatal intensive care unit and treated with antibiotics will be excluded from the study

研究组 & 干预措施

preoperative antibiotic

Active Comparator

iv Cefuroxime 1,5g administered 15-60 minutes before incision

干预措施: Cefuroxime (Drug)

postoperative antibiotic

Active Comparator

iv Cefuroxime 1,5g administered after umbilical cord clamping

干预措施: Cefuroxime (Drug)

结局指标

主要结局

Maternal: incidence of post-CS infection (endometritis, urinary tract infections and wound infection) in each study group

时间窗: Within the first 30 days after surgery

Infant: fecal microbiota at the tenth day of life

时间窗: on the tenth day of life

次要结局

  • Maternal: Length of hospitalization(Within the first 30 days after Caesarean Section)
  • Infant: concentration of cefuroxime in blood samples(during the first 24 hours of life)
  • Infant: immunological analyses in blood samples on day 3(On the third day of life)
  • Maternal: readmissions to hospital on suspicion of postpartum infection following cesarean section(Within the first 30 days after Caesarean Section)
  • Antibiotic treatment(within the first 30 days after Caesarean Section)

研究者

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

Nana Hyldig

PhD Student

Odense University Hospital

研究点 (1)

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