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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158609
Recruitment Status : Completed
First Posted : November 12, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Özkan Özdamar, Istanbul Medeniyet University

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.

Condition or disease Intervention/treatment
Term Pregnancy Doppler Parameters Induction of Labor Fetal Complications Diagnostic Test: Doppler flow indices assessment

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.

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Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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.
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Group 1
Pregnant women with CPR value below 1, based on Doppler indices assessment
Diagnostic Test: Doppler flow indices assessment
Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor

Group 2
Pregnant women with CPR value equal to or above 1, based on Doppler indices assessment
Diagnostic Test: Doppler flow indices assessment
Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor




Primary Outcome Measures :
  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 Outcome Measures :
  1. Route of delivery [ Time Frame: At the time of delivery ]
    Route of delivery, either vaginally or by cesarean section



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158609


Locations
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Turkey
Istanbul Medeniyet University
İstanbul, Turkey, 34722
Sponsors and Collaborators
Istanbul Medeniyet University
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Responsible Party: Özkan Özdamar, M.D., Principal Investigator, Clinical Investigator of OB&GYN, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT04158609    
Other Study ID Numbers: 2018/0473
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Özkan Özdamar, Istanbul Medeniyet University:
term pregnancy
Doppler parameters
Cerebroplacental ratio
Induction of labor