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

Not Applicable

Not yet recruiting

• Conditions: Perineal Infection; Maternal Infections Affecting Fetus or Newborn; Cost Effectiveness

• Registration Number: NCT06880445
• Lead Sponsor: Tzu-Ying Huang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Status Verified: 2025-03
• Study Start: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

Maternity:

• 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.

Newborn:

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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