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Completed

NCT Number: NCT02456753

Assesment by Ultrasonography of the Perineal-cephalic Distance

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.

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Key information

Conditions

Ultrasonography, Prenatal

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Saint Vincent de Paul (GHICL)

Lille, Hauts-de-France, 59000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trans-perineal ultrasonography

Device

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

Primary outcomes

  1. Perineal-cephalic distance measured in milimeters

    Time frame: one day

    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

Secondary outcomes

  1. Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneum

    Time frame: one day

    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

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: ECHOTRANS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 28, 2015
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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