Relationship Between Delivery Route and Fetal Complications With Doppler Indices and CPR Parameters

Completed

• Conditions: Term Pregnancy; Doppler Parameters; Induction of Labor; Fetal Complications
• Interventions: Diagnostic Test: Doppler flow indices assessment

• Registration Number: NCT04158609
• Lead Sponsor: Istanbul Medeniyet University

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.

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-31
• Status Verified: 2019-11
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-08
• Study First Posted: 2019-11-12
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Doppler flow indices assessment	Pregnant women with CPR value equal to or above 1, based on Doppler indices assessment
Group 1	Doppler flow indices assessment	Pregnant women with CPR value below 1, based on Doppler indices assessment

Primary Outcome Measures

Name	Time	Method
APGAR score at 5 minutes	Postpartum 5 minutes	APGAR score determined by the pediatrician at postpartum 5 minutes
Newborn intensive care unit administration	Within postpartum 1 month period	Newborn intensive care unit administration, due to a variety of conditions, which were established by pediatrician
Meconium aspiration syndrome	Within postpartum two weeks	Meconium aspiration syndrome diagnosed by the pediatrician, either clinically or by thorax X-ray film.
Neonatal sepsis	Within postpartum 1 month period	Neonatal sepsis diagnosed by the pediatrician
Neonatal death	Within postpartum 1 month period	Neonatal death
Umblical arter pH	Within 1-3 minutes following delivery	Umbilical cord blood sampling just after the delivery of the newborn and pH measurement

Secondary Outcome Measures

Name	Time	Method
Route of delivery	At the time of delivery	Route of delivery, either vaginally or by cesarean section

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 İstanbul, Turkey