Clinical trial NCT04158609: Relationship Between Delivery Route and Fetal Complications With Doppler Indices and CPR Parameters
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Term Pregnancy
Doppler Parameters
Induction of Labor
Fetal Complications
Keywords: term pregnancy
Doppler parameters
Cerebroplacental ratio
Induction of labor
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Umblical arter pH
timeFrame: Within 1-3 minutes following delivery
measure: APGAR score at 5 minutes
timeFrame: Postpartum 5 minutes
measure: Meconium aspiration syndrome
timeFrame: Within postpartum two weeks
measure: Newborn intensive care unit administration
timeFrame: Within postpartum 1 month period
measure: Neonatal sepsis
timeFrame: Within postpartum 1 month period
measure: Neonatal death
timeFrame: Within postpartum 1 month period
Secondary outcomes:
measure: Route of delivery
timeFrame: At the time of delivery
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References: