NCT02456753|Completed
Assesment by Ultrasonography of the Perineal-cephalic Distance
ECHOTRANS
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ECHOTRANS
Sponsor study identifier
observational
411
1 country
1
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 13, 2015
Actual (reported)May 28, 2015
Actual (reported)September 2015
Actual (reported)September 2015
Actual (reported)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
Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneum
one day
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.
Assesment of the fetal head-perineum distance via a trans-perineal ultrasonography
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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.
Hôpital Saint Vincent de Paul (GHICL)
Lille, Hauts-de-France, 59000, France
Sophie Desurmont, MD
Groupment des Hôpitaux de l'Institut Catholique de Lille
411 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2015
First Posted
May 28, 2015
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Instinct™ Ultrasound Device Safety, Efficacy and Usability
Contact the study team to confirm eligibility.
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)Last Updated
September 20, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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