Clinical Trials Directory

Trials / Completed

CompletedNCT04158609

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

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.

Status
Completed
Phase
Study type
Observational
Enrollment
145 (actual)
Sponsor
Istanbul Medeniyet University · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTDoppler flow indices assessmentDoppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor

Timeline

Start date
2018-12-01
Primary completion
2019-09-30
Completion
2019-10-31
First posted
2019-11-12
Last updated
2019-11-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04158609. Inclusion in this directory is not an endorsement.