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Search / Trial NCT06880445

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

Launched by TZU-YING HUANG · Mar 11, 2025

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

Perineal Cleaning And Disinfection Maternal/Neonatal Infections Cost Effectiveness

ClinConnect Summary

This clinical trial is investigating the best way to prepare the perineal area (the area between the vagina and the anus) before vaginal birth, with a focus on preventing infections in mothers and newborns while also looking at how it affects medical costs. Traditionally, disinfectants like povidone-iodine are used during delivery, but this study is exploring whether using just clean water might be just as effective. Researchers believe that using clean water may help preserve beneficial bacteria that support healthy development in newborns and that it won’t increase the risk of infections for mothers or babies.

To take part in the study, pregnant women must be at least 18 years old, be having a low-risk, single pregnancy, and not have used antibiotics during pregnancy. Newborns need to be healthy and meet certain criteria at birth. Participants will be randomly assigned to either use clean water or povidone-iodine for perineal preparation during delivery. Throughout the trial, researchers will monitor the health of both mothers and babies to see if there are differences in infection rates and costs. This study aims to improve care during delivery while potentially lowering healthcare expenses.

Gender

FEMALE

Eligibility criteria

  • 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

About Tzu Ying Huang

Tzu-Ying Huang is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a strong focus on precision medicine and evidence-based practices, Tzu-Ying Huang leads initiatives that encompass a wide range of therapeutic areas. The organization emphasizes collaboration with healthcare professionals, regulatory bodies, and research institutions to ensure the highest standards of clinical trial design and execution. By leveraging cutting-edge methodologies and a patient-centric approach, Tzu-Ying Huang strives to contribute significantly to the development of safe and effective treatments, ultimately enhancing the quality of care in the medical community.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported