NCT05033275

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

3.7 years

First QC Date

August 19, 2021

Last Update Submit

April 15, 2025

Conditions

Infant of Diabetic MotherSacral Agenesis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infants born to mothers with pregestational diabetes

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MU

Columbia, Missouri, 65201, United States

Location

Related Publications (1)

  • Gajagowni S, Mazuru-Witten D, Hegstrom J, Goodman J, Vachharajani AJ. Ultrasound-Guided Prospective Screening for Spinal Dysraphism in Offspring of Mothers With Pregestational Diabetes: A Pilot Study. J Ultrasound Med. 2023 Dec;42(12):2867-2872. doi: 10.1002/jum.16327. Epub 2023 Oct 4.

    PMID: 37792458DERIVED

MeSH Terms

Conditions

Sacral defect and anterior sacral meningocele

Study Officials

  • Akshaya J Vachharajani, MD

    MU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

August 19, 2021

First Posted

September 2, 2021

Study Start

May 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

No data sharing

Locations

US(1)