NCT01436409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 29, 2011

Status Verified

July 1, 2011

Enrollment Period

5.8 years

First QC Date

August 8, 2011

Last Update Submit

November 25, 2011

Conditions

Assisted Delivery

Keywords

vaginal touchdeliveries assistedechographyassisted delivery

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

    two days

Study Arms (2)

only vaginal touch

OTHER
Other: echography

vaginal touch +echography

EXPERIMENTAL
Other: echography

Interventions

echographyOTHER

echography during labor

only vaginal touchvaginal touch +echography

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Poissy St Germain

Poissy, 78320, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • patrick Rozenberg, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2011

First Posted

September 19, 2011

Study Start

December 1, 2005

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 29, 2011

Record last verified: 2011-07

Locations

FR(1)