Rates of Fetal Extractions Between Only Vaginal Touch Usu... | NCT01436409

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

NCT01436409

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 29, 2011Estimated

Enrollment

1,900Actual

Phase

Not Applicable

Conditions

Assisted Delivery

Interventions

echography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005/0570	Other Identifier	DGS

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Aug 8, 2011

First Submission Date that Met QC Criteria

Sep 16, 2011

First Posted Date

Sep 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2011

Last Update Posted Date

Nov 29, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,900Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
only vaginal touch	Other		Other: echography
vaginal touch +echography	Experimental		Other: echography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
echography	Other	echography during labor	only vaginal touch vaginal touch +echography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	TWO DAYS

Secondary Outcomes

Measure	Description	Time Frame
to optimize the coverage delivery in case of extraction by pair of forceps or suction cup.	If systematic echography during labor optimize the coverage delivery in case of extraction by pair of forceps or suction cup.	two days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
patrick Rozenberg, PU-PH	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chi Poissy St Germain		Poissy		78320	France

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

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Browse Branches

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