Status:

COMPLETED

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

Lead Sponsor:

Tzu-Ying Huang

Conditions:

Perineal Infection

Maternal Infections Affecting Fetus or Newborn

Eligibility:

FEMALE

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 30 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2025

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT06880445

Start Date

November 30 2024

End Date

July 1 2025

Last Update

August 15 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Far Eastern Memorial Hospital

New Taipei City, Banqiao District, Taiwan, 220