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

Terminated

• Conditions: Infant of Diabetic Mother; Sacral Agenesis

• Registration Number: NCT05033275
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound	12 months	All babies who have tethered cord on spinal US will be referred to neurosurgery

Trial Locations

Locations (1)

MU; 🇺🇸 Columbia, Missouri, United States