Assesment by Ultrasonography of the Perineal-cephalic Distance

Overview

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.

Full Title of Study: “Assesment by Ultrasonography of the Perineal-cephalic Distance in Consistence With the Notion of Clinical Fetal Head Engagement”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: September 2015

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

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lille Catholic University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sophie Desurmont, MD, Principal Investigator, Groupment des Hôpitaux de l’Institut Catholique de Lille

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