Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy

Infant of Diabetic Mother Clinical Trial

Official title:

Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033275
• Other study ID #: 2047262
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: University of Missouri-Columbia
• Contact: Akshaya Vachharajani, MD
• Phone: 5738822282
• Email: vachharajaniaj[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis

Description:

Parent/s of babies born to mothers with pregestational diabetes who have normal clinical examination and have no radiographs showing a normal sacrum will be approached for a spinal US

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Infants born to mothers with pregestational diabetes
• Normal spinal examination

Exclusion Criteria:

• Infants born to mothers with pregestational diabetes
• Abnormal spinal examination such as a sacral dimple
• Radiograph with abnormal sacrum
• Spanish speaking parents

Related Conditions & MeSH terms

• Abnormalities, Multiple
• Diabetes, Gestational
• Infant of Diabetic Mother
• Meningocele
• Pregnancy in Diabetics
• Sacral Agenesis

Locations

Country	Name	City	State
United States	MU	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound	All babies who have tethered cord on spinal US will be referred to neurosurgery	12 months