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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Term Pregnancy, Doppler Parameters, Induction of Labor, Fetal Complications

Intervention / Treatment
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* Diagnostic Test: Doppler flow indices assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Pregnant women with CPR value below 1, based on Doppler indices assessment | Diagnostic Test: Doppler flow indices assessment<br>* Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor<br>|
| Group 2<br>Pregnant women with CPR value equal to or above 1, based on Doppler indices assessment | Diagnostic Test: Doppler flow indices assessment<br>* Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umblical arter pH | Umbilical cord blood sampling just after the delivery of the newborn and pH measurement | Within 1-3 minutes following delivery | 
| APGAR score at 5 minutes | APGAR score determined by the pediatrician at postpartum 5 minutes | Postpartum 5 minutes | 
| Meconium aspiration syndrome | Meconium aspiration syndrome diagnosed by the pediatrician, either clinically or by thorax X-ray film. | Within postpartum two weeks | 
| 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 | 
| Neonatal sepsis | Neonatal sepsis diagnosed by the pediatrician | Within postpartum 1 month period | 
| Neonatal death | Neonatal death | Within postpartum 1 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Route of delivery | Route of delivery, either vaginally or by cesarean section | At the time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebroplacental ratio, term pregnancy, Doppler parameters, Induction of labor