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临床试验/NCT04416022
NCT04416022Unknown不适用

Cervical Gland Area as a Predictor of Success of Labour Induction

Rambam Health Care Campus0 个研究点目标入组 100 人开始时间: 2020年6月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Onset of active labour

研究概览

简要总结

Women who fulfil the inclusion criteria and who are planned for labour induction will be recruited. Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process, and patient information and maternal and neonatal outcome will be documented following the delivery.

详细描述

Patient consent to participate in the study will be retrieved following the medical decision of labor induction and the mode of induction and following the patient consent to the induction.

Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process.

The method of induction, data regarding patient demographics, the progress of labor, and the maternal and neonatal outcome will be documented following the delivery.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton and twins' pregnancies
  • Pregnancy 34-41 weeks of gestation
  • Vertex presentation
  • Induction methods (Oxytocin, prostaglandin 1 (PGE1), prostaglandin 2 (PGE2), double balloon catheter, rupture of memebrane (ROM)

排除标准

  • Intrauterine fetal demise (IUFD)
  • Contraindication to vaginal delivery
  • Status post cervical cerclage
  • Previous attempt of labor induction
  • History of cervical surgery
  • Active vaginal bleeding

结局指标

主要结局

Onset of active labour

时间窗: Up to delivery

Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)

次要结局

  • Rate of vaginal delivery(Up to delivery)
  • Time from Induction to delivery(Up to delivery)
  • Neonatal outcome - PH(Up to 10 minutes from delivery)
  • Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)(Up to 5 minutes from delivery)
  • Time from Induction to second stage(Up to delivery)
  • Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission(Up to 48 hours from delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SAAR AHARONI MD

Dr. Saar Aharoni

Rambam Health Care Campus

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