NCT06880445

Different Perineal Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Tzu-Ying Huang · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Perineal Infection
• Maternal Infections Affecting Fetus or Newborn
• Cost Effectiveness

Interventions

Type	Name	Description
PROCEDURE	Povidone-Iodine (PVP-I)	The experimental group will use povidone-iodine for disinfection.
PROCEDURE	Water	The control group will undergo perineal preparation using clean water

Timeline

• Start date: 2024-11-30
• Primary completion: 2025-06-25
• Completion: 2025-07-01
• First posted: 2025-03-17
• Last updated: 2025-08-15

Locations

1 site across 1 country: Taiwan