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

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.

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.

Study Overview

• Status: Completed
• Conditions: Fetal Complications; Induction of Labor; Term Pregnancy; Doppler Parameters
• Intervention / Treatment: Diagnostic test: Doppler flow indices assessment

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 Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34722
    • Istanbul Medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Pregnant women with CPR value below 1, based on Doppler indices assessment	Diagnostic test: Doppler flow indices assessment; Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor
Group 2; Pregnant women with CPR value equal to or above 1, based on Doppler indices assessment	Diagnostic test: Doppler flow indices assessment; Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Induction of labor; term pregnancy; Doppler parameters; Cerebroplacental ratio
• Other Study ID Numbers: 2018/0473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No