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Clinical Trials/NCT04158609
NCT04158609
Completed
Not Applicable

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.

Istanbul Medeniyet University1 site in 1 country145 target enrollmentDecember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Term Pregnancy
Sponsor
Istanbul Medeniyet University
Enrollment
145
Locations
1
Primary Endpoint
APGAR score at 5 minutes
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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. All women who were considered appropriate for induction of labor were performed an pelvic examination and their Bishop scores were calculated. Those with a Bishop score equal to or below 5 were included in the study. Vaginal misoprostol (prostoglandin E1, 25 mcg) and dinoproston (prostoglandin E2, 10 mg) were used for induction of labor. Repeat doses were implemented in case of insufficient cervical ripening. Oxytocin was not used at the initial stages of labour, while it was used at the latter stages when necessary. 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
October 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Istanbul Medeniyet University
Responsible Party
Principal Investigator
Principal Investigator

Özkan Özdamar

M.D., Principal Investigator, Clinical Investigator of OB&GYN

Istanbul Medeniyet University

Eligibility Criteria

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

Outcomes

Primary Outcomes

APGAR score at 5 minutes

Time Frame: Postpartum 5 minutes

APGAR score determined by the pediatrician at postpartum 5 minutes

Newborn intensive care unit administration

Time Frame: Within postpartum 1 month period

Newborn intensive care unit administration, due to a variety of conditions, which were established by pediatrician

Meconium aspiration syndrome

Time Frame: Within postpartum two weeks

Meconium aspiration syndrome diagnosed by the pediatrician, either clinically or by thorax X-ray film.

Neonatal sepsis

Time Frame: Within postpartum 1 month period

Neonatal sepsis diagnosed by the pediatrician

Neonatal death

Time Frame: Within postpartum 1 month period

Neonatal death

Umblical arter pH

Time Frame: Within 1-3 minutes following delivery

Umbilical cord blood sampling just after the delivery of the newborn and pH measurement

Secondary Outcomes

  • Route of delivery(At the time of delivery)

Study Sites (1)

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