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临床试验/NCT04158609
NCT04158609已完成不适用

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.

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
145
试验地点
1
主要终点
APGAR score at 5 minutes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

APGAR score at 5 minutes

时间窗: Postpartum 5 minutes

APGAR score determined by the pediatrician at postpartum 5 minutes

Newborn intensive care unit administration

时间窗: Within postpartum 1 month period

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

Meconium aspiration syndrome

时间窗: Within postpartum two weeks

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

Neonatal sepsis

时间窗: Within postpartum 1 month period

Neonatal sepsis diagnosed by the pediatrician

Neonatal death

时间窗: Within postpartum 1 month period

Neonatal death

Umblical arter pH

时间窗: Within 1-3 minutes following delivery

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

次要结局

  • Route of delivery(At the time of delivery)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özkan Özdamar

M.D., Principal Investigator, Clinical Investigator of OB&GYN

Istanbul Medeniyet University

研究点 (1)

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