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

NCT ID: NCT05033275

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Infant of Diabetic Mother Sacral Agenesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Akshaya Vachharajani

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akshaya J Vachharajani, MD

Role: PRINCIPAL_INVESTIGATOR

MU

Locations

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MU

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37792458 (View on PubMed)

Other Identifiers

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2047262

Identifier Type: -

Identifier Source: org_study_id

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