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

April 15, 2025 updated by: Akshaya Vachharajani, University of Missouri-Columbia
Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65201
        • MU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants born to mothers with pregestational diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound
Time Frame: 12 months
All babies who have tethered cord on spinal US will be referred to neurosurgery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Akshaya J Vachharajani, MD, MU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2047262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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