Clinical Trials Directory

Trials / Completed

CompletedNCT05045560

Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020)

Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020) : Why and How to Improve Antenatal Counseling ?

Status
Completed
Phase
Study type
Observational
Enrollment
98 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Objective : Anorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation. The impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period. The objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling. Materials and methods : In this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.

Conditions

Timeline

Start date
2010-01-01
Primary completion
2021-08-01
Completion
2021-08-30
First posted
2021-09-16
Last updated
2021-09-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05045560. Inclusion in this directory is not an endorsement.