CClinicalTrials.gg
CompletedNCT04158609DopplerUpdated Nov 13, 2019

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

An observational study in Term Pregnancy, Doppler Parameters and Induction of Labor, sponsored by Istanbul Medeniyet University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Istanbul Medeniyet University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
145
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • term pregnancy
  • Doppler parameters
  • Cerebroplacental ratio
  • Induction of labor
03

In context

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 188 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • Term pregnancies between 37 and 41 gestational weeks Pregnancies destined to induction of labor

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
145 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    Pregnant women with CPR value below 1, based on Doppler indices assessment

    Diagnostic Test: Doppler flow indices assessment

  • Group 2

    Pregnant women with CPR value equal to or above 1, based on Doppler indices assessment

    Diagnostic Test: Doppler flow indices assessment

Interventions

  • Diagnostic testDoppler flow indices assessment

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

06

What researchers measure

Primary outcomes

  1. Umblical arter pH

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

    Time frame: Within 1-3 minutes following delivery

  2. APGAR score at 5 minutes

    APGAR score determined by the pediatrician at postpartum 5 minutes

    Time frame: Postpartum 5 minutes

  3. Meconium aspiration syndrome

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

    Time frame: Within postpartum two weeks

  4. Newborn intensive care unit administration

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

    Time frame: Within postpartum 1 month period

  5. Neonatal sepsis

    Neonatal sepsis diagnosed by the pediatrician

    Time frame: Within postpartum 1 month period

  6. Neonatal death

    Neonatal death

    Time frame: Within postpartum 1 month period

Secondary outcomes

  1. Route of delivery

    Route of delivery, either vaginally or by cesarean section

    Time frame: At the time of delivery

07

Study locations

1 site
  • Istanbul Medeniyet University
    İstanbul, 34722, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04158609
Lead sponsor
Istanbul Medeniyet University
Responsible party
Özkan Özdamar (M.D., Principal Investigator, Clinical Investigator of OB&GYN, Istanbul Medeniyet University) — Principal investigator
First posted
Nov 12, 2019
Start date
Dec 1, 2018
Primary completion
Sep 30, 2019
Completion
Oct 31, 2019
Last update
Nov 13, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion