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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Term Pregnancy Doppler Parameters Induction of Labor Fetal Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Doppler flow indices assessment

Intervention Type DIAGNOSTIC_TEST

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

Doppler flow indices assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Doppler flow indices assessment

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes