Infant of Diabetic MotherNCT05033275
Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy
An observational study of Infant of Diabetic Mother and Sacral Agenesis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant of Diabetic Mother, Sacral Agenesis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants born to mothers with pregestational diabetes
Who may be able to join
- Infants born to mothers with pregestational diabetes
- Normal spinal examination
Who cannot join
- Infants born to mothers with pregestational diabetes
- Abnormal spinal examination such as a sacral dimple
- Radiograph with abnormal sacrum
- Spanish speaking parents
Trial locations and contacts
1 site in 1 country.
About this study
Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis
Read the 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
- Conditions
- Infant of Diabetic Mother, Sacral Agenesis
- Medical subject headings
- Sacral defect and anterior sacral meningocele
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 May 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant of Diabetic MotherStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akshaya Vachharajani, University of Missouri-Columbia
- Investigators
- Akshaya J Vachharajani, MD, Principal investigator, MU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033275
- Sponsor's protocol ID
- 2047262
- Status last verified
- Apr 2025
- First submitted
- 19 Aug 2021
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing
Publications
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.
PubMed 37792458
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy
- ClinicalTrials.gov ID
- NCT05033275
- Acronym / sponsor ID
- 2047262
- Conditions
- Infant of Diabetic Mother, Sacral Agenesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born to mothers with pregestational diabetes
Key inclusion criteria (2 listed)
- Infants born to mothers with pregestational diabetes
- Normal spinal examination
Key exclusion criteria (4 listed)
- Infants born to mothers with pregestational diabetes
- Abnormal spinal examination such as a sacral dimple
- Radiograph with abnormal sacrum
- Spanish speaking parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Derived from this study: PubMed 37792458Gajagowni 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.
- Individual participant dataSharing planned: No. No data sharing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akshaya J Vachharajani, MD principal investigator
MU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant of Diabetic Mother and Sacral Agenesis, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05033275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.