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Completed

NCT Number: NCT04158609

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul Medeniyet University

Istanbul, 34722, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doppler flow indices assessment

Diagnostic Test

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

Primary outcomes

  1. Umblical arter pH

    Time frame: Within 1-3 minutes following delivery

    Umbilical cord blood sampling just after the delivery of the newborn and pH measurement

  2. APGAR score at 5 minutes

    Time frame: Postpartum 5 minutes

    APGAR score determined by the pediatrician at postpartum 5 minutes

  3. Meconium aspiration syndrome

    Time frame: Within postpartum two weeks

    Meconium aspiration syndrome diagnosed by the pediatrician, either clinically or by thorax X-ray film.

  4. Newborn intensive care unit administration

    Time frame: Within postpartum 1 month period

    Newborn intensive care unit administration, due to a variety of conditions, which were established by pediatrician

  5. Neonatal sepsis

    Time frame: Within postpartum 1 month period

    Neonatal sepsis diagnosed by the pediatrician

  6. Neonatal death

    Time frame: Within postpartum 1 month period

    Neonatal death

Secondary outcomes

  1. Route of delivery

    Time frame: At the time of delivery

    Route of delivery, either vaginally or by cesarean section

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study 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.

Acronym: Doppler

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 12, 2019
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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