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Rates of Fetal Extractions Between Only Vaginal Touch Usually Realized and Vaginal Touch + Echography

NCT ID: NCT01436409

Last Updated: 2011-11-29

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

Clinical Phase

NA

Total Enrollment

1900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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

Criteria of efficiency Rate of deliveries attended defined by a composite criteria: deliveries by caesarian from a dilation of the cervix = 8 cms, and instrumental extractions by pair of forceps or suction cup.

Conditions

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Assisted Delivery

Keywords

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vaginal touch deliveries assisted echography assisted delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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only vaginal touch

Group Type OTHER

echography

Intervention Type OTHER

echography during labor

vaginal touch +echography

Group Type EXPERIMENTAL

echography

Intervention Type OTHER

echography during labor

Interventions

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echography

echography during labor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* caesarian antecedent, preeclampsia, praevia placental
* maternal and pregnancy pathology
* included in other trial
* absent consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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patrick Rozenberg, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Chi Poissy St Germain

Poissy, , France

Site Status

Countries

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France

Other Identifiers

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2005/0570

Identifier Type: OTHER

Identifier Source: secondary_id

P050304

Identifier Type: -

Identifier Source: org_study_id