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临床试验/NCT03430804
NCT03430804已完成不适用

Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour at Term for Prediction of Caesarean Delivery

Ain Shams University1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2017年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
Cervical length

研究概览

简要总结

Transvaginal sonographic measurement of cervical length versus Bishop score in labour induction at term for prediction of Caesarean delivery. This study is prospective study. This study will be carried out in Ain-shams maternity hospital. Sample size of 320 parturients.

详细描述

Patients and Methods

Study design:

This study is prospective study, comparative clinical trial for a test against a gold standard with blinding of the evaluator

Study setting:

This study will be carried out in Ain-Shams university maternity hospital.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age (18-35) years.
  • Singleton pregnancy.
  • (37-42) weeks gestation.
  • Living fetus.
  • Cephalic presentation.
  • Absence of active labour.
  • No contraindication to vaginal delivery.
  • Average amount of clear liquor.
  • No history of uterine scar (myomectomy or previous C.S(.

排除标准

  • Malpresentation.
  • Major fetal congenital anomalies as hydrocephalous & dead fetus.
  • Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins).
  • Any medical history contraindicating vaginal delivery.
  • Assessment meconium staining to liquor or any evidence of chorioamnionitis.
  • Previous uterine surgery.
  • Multiple gestations.
  • Women with allergy to prostaglandins.

结局指标

主要结局

Cervical length

时间窗: 24 hours

median cervical length measured by transvaginal ultrasound in centimetres.

Bishop score

时间窗: 72

median Bishop score assessed by digital vaginal examination as follows: Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilatation. Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more. Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more. Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated. Note that a score more than 10 means patient is in labor not needing induction of labor.

次要结局

未报告次要终点

研究者

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

Mohamed Adel Mazroa

Dr resident of obstetrics and gynecology

Ain Shams University

研究点 (1)

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