Development of a new intrapartum fetal monitoring technique using a finger-mounted fetal tissue oximeter: a multicenter study

Not Applicable

• Conditions: Pregnant women over 36 weeks of gestation and who will undergo transvaginal delivery

• Registration Number: JPRN-UMIN000020738
• Lead Sponsor: Hamamatsu University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Study Completion: 2018-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1. Multiple pregnancies 2. Previously underwent myomectomy and/or cesarean section 3. Fetal malpresentation 4. Malposition of the placenta

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish standard values for fetal tissue oxygen saturation and total hemoglobin index during the first and second stages of labor and the newborn's tissue oxygen saturation and total hemoglobin index after birth.

Secondary Outcome Measures

Name	Time	Method
1. Incidence of abnormal fetal heart rate monitoring in newborns whose umbilical cord artery blood pH is >7.25 and the Apgar score is >8. 2. Incidence of normal fetal tissue oxygen saturation and total hemoglobin index in patients who fulfill a key secondary outcome of 1. 3. Incidence of normal fetal heart rate monitoring in newborns whose umbilical cord artery blood pH is <7.25 and the Apgar score is <8. 4. Incidence of abnormal fetal tissue oxygen saturation and total hemoglobin index in patients who fulfill a key secondary outcome of 3. 5. Fetal tissue oxygen saturation and total hemoglobin index in patients with abnormal fetal heart rate.