Pregnant women over 36 weeks of gestation and who will undergo transvaginal delivery
Conditions
Interventions
Finger-mounted fetal tissue oximeter
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women over 36 weeks of gestation and who will undergo transvaginal delivery. 2. Patients who have voluntarily provided written consent to participate in this trial, after having been thoroughly briefed and informed of the nature of the trial [if the patient is <20 years old, written consent must be obtained from the husband (>20 years) or a parent].
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancies 2. Previously underwent myomectomy and/or cesarean section 3. Fetal malpresentation 4. Malposition of the placenta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactUchida Toshiyuki
Hamamatsu University School of Medicine Department of Obstetrics and Gynecology
Outcome results
None listed