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

Anorectal Malformations Clinical Trial

Official title:

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 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045560
• Other study ID #: RECHMPL20_0616
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 30, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• foreign-born patient

• anorectal malformation associated with an abdominal wall defect

Related Conditions & MeSH terms

• Anorectal Malformations
• Congenital Abnormalities

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ante or post-natal diagnosispremolars	Number of ante or post-natal diagnosis	1 day
Secondary	Number of with or without associated antenatal anomalies	Number of with or without associated antenatal anomalies	1 day