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临床试验/NCT01436409
NCT01436409已完成不适用

Comparison of the Rates of Fetal Extractions Between a Systematic Practice of an Echography of Presentation and the Only Vaginal Touch Usually Realized During the Labor

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 1,900 人开始时间: 2005年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,900
试验地点
2
主要终点
to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.

研究概览

简要总结

The main objective of this study is to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.

详细描述

The main objective is to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.

It is a prospective, randomized study. After randomization, the patients will be assigned to one of following both groups:

  • Diagnosis of the variety of presentation of the fetal head by the usual examination, that is the only vaginal touch allowing the palpation of the sutures of the fetal head to locate the axis and the orientation of this one in the maternal pond. However, this clinical examination can be completed by an echography if the team considers that this information is necessary to optimize the coverage delivery in case of extraction by pair of forceps or suction cup.
  • Diagnosis of the variety of presentation of the fetal head by the vaginal touch, confirmed by the systematic practice of an abdominal echography completed by a perineal echography from 8 cms of dilation, and made for a maximal extension of 15 minutes following the vaginal touch. This echography will be at the need repeated

1900 patients (that is 950 by group) have to allow to detect a decrease of 25 % of the rate of deliveries assisted in the experimental group (systematic echography) with regard to the control group (TV), that is a decrease absolved from the rate from 20 % to 15 %, with a 80 % power and a risk of 5 % (bilateral test).

Duration of participation in the study: = 2 days Duration of the inclusions: 36 months

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥ 18 years
  • singleton pregnancy in head presentation
  • gestational age ≥ 37 WG
  • dilation of the cervix = 8 cms

排除标准

  • caesarian antecedent, preeclampsia, praevia placental
  • maternal and pregnancy pathology
  • included in other trial
  • absent consent

结局指标

主要结局

to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.

时间窗: TWO DAYS

to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.

次要结局

  • to optimize the coverage delivery in case of extraction by pair of forceps or suction cup.(two days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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