Assesment by Ultrasonography of the Perineal-cephalic Distance (ECHOTRANS)

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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography, Prenatal
• Intervention / Treatment: Device: trans-perineal ultrasonography

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• France
  • Nord Pas De Calais
    • Lille, Nord Pas De Calais, France, 59000
      • Hôpital Saint Vincent de Paul (GHICL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients included are women about to give birth, they undergo a clinical examination done by midwives. Followed by a trans-perineal ultrasonography examination done by a technical operator in order to measure the perineal-cephalic distance.

These examination are done the day of enrollment, they last for a few minutes and no further tests will be done afterwards.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
trans-perineal ultrasonography; Patients included are women about to give birth, they undergo a clinical examination done by midwives. Followed by a trans-perineal ultrasonography examination done by a technical operator in order to measure the perineal-cephalic distance. These examination are done the day of enrollment, they last for a few minutes and no further tests will be done afterwards.	Device: trans-perineal ultrasonography; Assesment of the fetal head-perineum distance via a trans-perineal ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Sophie Desurmont, MD, Groupment des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasonography; clinical examination; Prenatal; in labor
• Other Study ID Numbers: RC-P0024