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

Induction of Labor Clinical Trial

— Doppler  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158609
• Other study ID #: 2018/0473
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Doppler Parameters
• Fetal Complications
• Induction of Labor
• Term Pregnancy

Intervention

Diagnostic Test:
• Doppler flow indices assessment
Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

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