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

NCT06880445 | Completed

• 1 other identifier: 113236-F
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Perineal cleaning and disinfection; Maternal/Neonatal Infections; Cost Effectiveness

Outcome Measures

Primary Outcomes (1)

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

  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.

  2Years

Study Arms (2)

Perineal Disinfection

EXPERIMENTAL

Procedure: Povidone-Iodine (PVP-I)

Perineal Cleaning

PLACEBO COMPARATOR

Procedure: Water

Interventions

Povidone-Iodine (PVP-I) PROCEDURE

The experimental group will use povidone-iodine for disinfection.

Perineal Disinfection

Water PROCEDURE

The control group will undergo perineal preparation using clean water

Perineal Cleaning

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tzu-Ying Huang: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Banqiao District, 220, Taiwan

Location

MeSH Terms

Interventions

Povidone-Iodine; Water

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Far Eastern Memorial Hospital Deputy Director of Nursing

Model Details: This stu dy used the Random Allocation Software developed by Mahmood Saghaei to randomly assign the research subjects into the control group and the experimental group. The control group used clean water to prepare the perineum for the second stage of labor, while the experimental group used betadine disinfection for perineal preparation for the second stage of labor.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: March 17, 2025
• Study Start: November 30, 2024
• Primary Completion: June 25, 2025
• Study Completion: July 1, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)