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

I

Istanbul Medeniyet University

Status

Completed

Conditions

Term Pregnancy
Fetal Complications
Doppler Parameters
Induction of Labor

Treatments

Diagnostic Test: Doppler flow indices assessment

Study type

Observational

Funder types

Other

Identifiers

NCT04158609
2018/0473

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

145 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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