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临床试验/NCT06880445
NCT06880445已完成不适用

Different Perineal Cleaning and Disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial

Tzu-Ying Huang2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年11月30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
发起方
入组人数
320
试验地点
2
主要终点
Different Perineal cleaning and disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial

研究概览

简要总结

The vaginal microbiome plays a crucial role in women's health, primarily composed of beneficial bacteria such as Lactobacillus, which help maintain an acidic environment in the vagina, preventing the growth of pathogens. Research indicates that the vaginal environment during pregnancy is more conducive to the growth of Lactobacillus. Traditionally, perineal disinfection is performed during vaginal delivery; however, studies have shown that excessive use of disinfectants like povidone-iodine may reduce the presence of Lactobacillus in the vagina. Furthermore, not using perineal disinfection does not increase the risk of postpartum infections for mothers and infants, and may even benefit the development of the newborn's microbiome. Considering the medical costs and nursing labor involved, this study aims to compare the effects of different perineal preparation methods on postpartum infection rates and medical costs, with the goal of improving maternal and infant care quality during delivery and reducing healthcare costs.

5、 Method This study employs an experimental research design. After obtaining informed consent from participants, they will be randomly assigned to either the control group or the experimental group using a random number table. The control group will undergo perineal preparation using clean water, while the experimental group will use povidone-iodine for disinfection. The study will document patient demographics, prenatal vital signs, maternal and infant postpartum temperatures, blood test results, and oral bacterial culture outcomes to monitor postpartum infection rates. The REEDA scale will be used to assess perineal wound healing.

6、Expected results: The anticipated results indicate that using clean water for perineal preparation will not increase the risk of postpartum infections for mothers and infants, while also saving medical costs. Additionally, water disinfection may allow newborns to acquire beneficial bacteria such as Lactobacillus from the mother's vagina during delivery, promoting healthy gut microbiome development.

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

性别
Female
接受健康志愿者
是

入选标准

  • •Born after 37 weeks of pregnancy;
  • •Pregnant women with low-risk pregnancy;
  • •Be able to communicate in Mandarin and Taiwanese, and be able to read Chinese;
  • •A single fetus with a cephalic position;
  • •Aged 18 years or above (inclusive) with clear consciousness and no cognitive impairment;
  • •Do not use antibiotics during pregnancy;
  • •There are no fetal diagnostic abnormalities during pregnancy check-up.
  • •Newborns over 37 weeks
  • •Apgar Score is greater than 7 points in the first minute of life
  • •Having given birth to a newborn and undergoing perineal cleaning/disinfection methods specified in the study during the second stage of labor

排除标准

  • •The mother's water broke for more than 18 hours during labor;
  • •Mother had a fever;
  • •Used vacuum suction during delivery;
  • •Shoulder dystocia;
  • •Fetal distress;
  • •A perineal wound of 3 degrees or above

研究组 & 干预措施

Perineal Cleaning

Placebo Comparator

干预措施: Water (Procedure)

Perineal Disinfection

Experimental

干预措施: Povidone-Iodine (PVP-I) (Procedure)

结局指标

主要结局

Different Perineal cleaning and disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial

时间窗: 2Years

Cases that agree to participate in the study will collect data on a self made login form. During the study period, perineal preparation and 24hours postpartum perineal wound healing was assessed using the REEDA scale at the time of discharge and on the day of discharge, and neonatal oral bacterial culture was performed by the researcher.

次要结局

未报告次要终点

研究者

发起方
Tzu-Ying Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tzu-Ying Huang

Far Eastern Memorial Hospital Deputy Director of Nursing

Far Eastern Memorial Hospital

研究点 (2)

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