Assesment by Ultrasonography of the Perineal-cephalic Distance

Ultrasonography, Prenatal Clinical Trial

— ECHOTRANS  

Official title:

Assesment by Ultrasonography of the Perineal-cephalic Distance in Consistence With the Notion of Clinical Fetal Head Engagement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456753
• Other study ID #: RC-P0024
• Status: Completed
• Phase: N/A
• First received: April 13, 2015
• Last updated: September 19, 2016
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can help to visualize elements that may not be observable after clinical examination. Moreover, it is known that a fetal head engagement can lead to an instrumental extraction and in case of error, which happens in some cases, fetal and maternal risks are possible.

These elements led to the investigators' hypothesis which is that a trans-perineal ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of doubt.

Description:

It's a monocentric, transversal, clinical trial regarding women giving birth at the GHICL's hospital Saint Vincent de Paul.

Clinical examinations will be done by the midwives following the indications given on the clinical form. A trans-perineal echography will then be done by technical operators following the ultrasonography form.

These examinations will only last a few minutes, no further tests will be done afterwards.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of 18 years old or older

• Primiparous

• Complete dilation of the cervix

• Gestational age of 37 weeks or more according to the date of amenorrhea - - Rupture of membranes

• Fetus in cephalic presentation

• Patient who has signed a consent form

Exclusion Criteria

• Patient for whom the fetus has died in uteri

• Patient who's coming for an abortion

• Fetus in breech or transverse presentation

• Gemellary pregnancy for which the fetus present a severe cardiac anomaly

• Patient under trusteeship or guardianship

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ultrasonography, Prenatal

Intervention

Device:
• trans-perineal ultrasonography
Assesment of the fetal head-perineum distance via a trans-perineal ultrasonography

Locations

Country	Name	City	State
France	Hôpital Saint Vincent de Paul (GHICL)	Lille	Nord Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perineal-cephalic distance measured in milimeters	Determine the perineal-cephalic distance via echographic examination, which gives a better sensitivity/specificity in comparison to the clinical examination considered as a gold standard	one day	No
Secondary	Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneum	Determine the interest of the echography measurement in specific conditions (variety of posterior presentations, caput succedaneum, work stagnation) regarding the diagnosis of engagement, in case of doubt concerning the clinical examination	one day	No