Skip to content

Assesment by Ultrasonography of the Perineal-cephalic Distance

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02456753
Acronym
ECHOTRANS
Enrollment
411
Registered
2015-05-28
Start date
2012-09-30
Completion date
2015-09-30
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasonography, Prenatal

Keywords

in labor, Ultrasonography, clinical examination, Prenatal

Brief 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.

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.

Interventions

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

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perineal-cephalic distance measured in milimetersone dayDetermine the perineal-cephalic distance via echographic examination, which gives a better sensitivity/specificity in comparison to the clinical examination considered as a gold standard

Secondary

MeasureTime frameDescription
Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneumone dayDetermine 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026