Assesment by Ultrasonography of the Perineal-cephalic Distance

NCT02456753 | Completed

• 1 other identifier: RC-P0024
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasonography, Prenatal

Keywords

in labor; Ultrasonography; clinical examination; Prenatal

Outcome Measures

Primary Outcomes (1)

• 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

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

  one day

Study Arms (1)

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.

Device: trans-perineal ultrasonography

Interventions

trans-perineal ultrasonography DEVICE

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

trans-perineal ultrasonography

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Hôpital Saint Vincent de Paul (GHICL)

Lille, Hauts-de-France, 59000, France

Location

Study Officials

• Sophie Desurmont, MD

  Groupment des Hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: May 28, 2015
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

FR (1)