Induction of Labor Clinical Trial
— DopplerOfficial title:
Assessment of the Relationship Between Delivery Route, Umbilical Cord pH and Fetal Complications With Doppler Parameters Measured Prior to Induction of Labor at Term Pregnancies.
NCT number | NCT04158609 |
Other study ID # | 2018/0473 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2018 |
Est. completion date | October 31, 2019 |
Verified date | November 2019 |
Source | Istanbul Medeniyet University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI. Cerebroplacental Ratio (CPR) was calculated by dividing MCA PI value to umbilical artery PI (MCA PI/UA PI=CPR).Included pregnant women were categorized as Group 1 and Group 2, which comprised of those with CPR value below 1.0 and above 1.0, respectively. Route of delivery and fetal complications, described as umbilical cord pH<7.20, APGAR score at 5 minutes <7, meconium aspiration syndrome, newborn intensive care unit admission, neonatal sepsis and neonatal death.
Status | Completed |
Enrollment | 145 |
Est. completion date | October 31, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Term pregnancies between 37 and 41 gestational weeks Pregnancies destined to induction of labor Exclusion Criteria: - history of uterine scar, nonverteks presentation, multiple pregnancies, use of vacuum of forceps at delivery, shoulder dystocia, confirmed fetal structural or chromosomal anomalies |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medeniyet University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medeniyet University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Umblical arter pH | Umbilical cord blood sampling just after the delivery of the newborn and pH measurement | Within 1-3 minutes following delivery | |
Primary | APGAR score at 5 minutes | APGAR score determined by the pediatrician at postpartum 5 minutes | Postpartum 5 minutes | |
Primary | Meconium aspiration syndrome | Meconium aspiration syndrome diagnosed by the pediatrician, either clinically or by thorax X-ray film. | Within postpartum two weeks | |
Primary | Newborn intensive care unit administration | Newborn intensive care unit administration, due to a variety of conditions, which were established by pediatrician | Within postpartum 1 month period | |
Primary | Neonatal sepsis | Neonatal sepsis diagnosed by the pediatrician | Within postpartum 1 month period | |
Primary | Neonatal death | Neonatal death | Within postpartum 1 month period | |
Secondary | Route of delivery | Route of delivery, either vaginally or by cesarean section | At the time of delivery |
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