NCT04158609

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

November 7, 2019

Last Update Submit

November 8, 2019

Conditions

Term PregnancyDoppler ParametersInduction of LaborFetal Complications

Keywords

term pregnancyDoppler parametersCerebroplacental ratioInduction of labor

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Route of delivery

    At the time of delivery

Study Arms (2)

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

Doppler flow indices assessmentDIAGNOSTIC_TEST

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

Group 1Group 2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • history of uterine scar, nonverteks presentation, multiple pregnancies, use of vacuum of forceps at delivery, shoulder dystocia, confirmed fetal structural or chromosomal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34722, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Principal Investigator, Clinical Investigator of OB&GYN

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 12, 2019

Study Start

December 1, 2018

Primary Completion

September 30, 2019

Study Completion

October 31, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

TU(1)