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Clinical Trials/NCT02456753
NCT02456753
Completed
Not Applicable

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

Lille Catholic University1 site in 1 country411 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ultrasonography, Prenatal
Sponsor
Lille Catholic University
Enrollment
411
Locations
1
Primary Endpoint
Perineal-cephalic distance measured in milimeters
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
September 2015
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lille Catholic University
Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneum(one day)

Study Sites (1)

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