MyelomeningoceleNCT07048691
Prenatal and Postnatal Ultrasonographic Evaluation of Myelomeningocele to Predict Post-Surgical Outcomes
An observational study of Myelomeningocele, run by Superior University at 1 site in Pakistan.
Trial summary
Myelomeningocele (MMC), also known as open spina bifida, is a serious congenital condition in which the cord and meninges protrude through the spinal column's defective bony encasement due to a defective closure of the posterior portion of the neural tube between the fourth week of pregnancy. Read more about this study
- Who is it for?
- Ages 28 to 40 weeks
- Conditions the study is for
- Myelomeningocele
- What is being tested?
- G.E HEALTHCARE ultrasound machine with high-resolution convex probe
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 28 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: After approval from the institutional ethical committee, a total number of patients presenting to the Radiology and Peads Neurosurgery department of Allied Hospital, Faisalabad, that met the inclusion criteria was selected. After obtaining informed consent from each patient and attendant of the patient, transabdominal ultrasound was examined longitudinal, transverse and oblique plans, ultrasound with a high- resolution convex probe was used by the radiologist.
Who may be able to join
- Gestational age 3rd trimester, Lesion between T1 and S1, Hindbrain herniation and Normal karyotype
Who cannot join
- Multiple gestation pregnancy
- Other fetal anomalies unrelated to myelomeningocele
- History of incompetent cervix, Other serious maternal medical conditions
- Inability to adhere to travel and follow-up requirements
- Contraindication to surgery and Inability to meet trial psychosocial criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Myelomeningocele (MMC), also known as open spina bifida, is a serious congenital condition in which the cord and meninges protrude through the spinal column's defective bony encasement due to a defective closure of the posterior portion of the neural tube between the fourth week of pregnancy.
Read the detailed description
The formation of the defect is influenced by both genetic and environmental factors, while the exact cause is yet unknown. There is currently no effective treatment for this common and debilitating central nervous system (CNS) dysfunction.
- Conditions
- Myelomeningocele
- Being tested
- G.E HEALTHCARE ultrasound machine with high-resolution convex probe
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G.E HEALTHCARE ultrasound machine with high-resolution convex probeDiagnostic test
After approval from the institutional ethical committee, a total number of patients presenting to the Radiology and Peads Neurosurgery department of Allied Hospital, Faisalabad, that met the inclusion criteria was selected. After obtaining informed consent from each patient and attendant of the patient, transabdominal ultrasound was examined longitudinal, transverse and oblique plans, ultrasound with a high- resolution convex probe was used by the radiologist
| Study group | Role | What they receive |
|---|---|---|
| G.E HEALTHCARE ultrasound machine with high-resolution convex probe | Not described Receives: Diagnostic Test: G.E HEALTHCARE ultrasound machine with high-resolution convex probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
self administered questioner
self administered questioner for yelomeningocele patients scroing range fron 0-40. 0 is for lower and 40 is worse and higher
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 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomeningoceleStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048691
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/909
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal and Postnatal Ultrasonographic Evaluation of Myelomeningocele to Predict Post-Surgical Outcomes
- ClinicalTrials.gov ID
- NCT07048691
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/909
- Conditions
- Myelomeningocele
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
Myelomeningocele (MMC), also known as open spina bifida, is a serious congenital condition in which the cord and meninges protrude through the spinal column's defective bony encasement due to a defective closure of the posterior portion of the neural tube between the fourth week of pregnancy.
Detailed description
The formation of the defect is influenced by both genetic and environmental factors, while the exact cause is yet unknown. There is currently no effective treatment for this common and debilitating central nervous system (CNS) dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G.E HEALTHCARE ultrasound machine with high-resolution convex probe | – | Diagnostic Test: G.E HEALTHCARE ultrasound machine with high-resolution convex probe |
Who may qualify
- Ages
- 28 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- After approval from the institutional ethical committee, a total number of patients presenting to the Radiology and Peads Neurosurgery department of Allied Hospital, Faisalabad, that met the inclusion criteria was selected. After obtaining informed consent from each patient and attendant of the patient, transabdominal ultrasound was examined longitudinal, transverse and oblique plans, ultrasound with a high- resolution convex probe was used by the radiologist.
Key inclusion criteria (1 listed)
- Gestational age 3rd trimester, Lesion between T1 and S1, Hindbrain herniation and Normal karyotype
Key exclusion criteria (5 listed)
- Multiple gestation pregnancy
- Other fetal anomalies unrelated to myelomeningocele
- History of incompetent cervix, Other serious maternal medical conditions
- Inability to adhere to travel and follow-up requirements
- Contraindication to surgery and Inability to meet trial psychosocial criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G.E HEALTHCARE ultrasound machine with high-resolution convex probeAfter approval from the institutional ethical committee, a total number of patients presenting to the Radiology and Peads Neurosurgery department of Allied Hospital, Faisalabad, that met the inclusion criteria was selected. After obtaining informed consent from each patient and attendant of the patient, transabdominal ultrasound was examined longitudinal, transverse and oblique plans, ultrasound with a high- resolution convex probe was used by the radiologist | Diagnostic test | G.E HEALTHCARE ultrasound machine with high-resolution convex probe |
Primary outcome
self administered questioner
Time frame: 12 Months
self administered questioner for yelomeningocele patients scroing range fron 0-40. 0 is for lower and 40 is worse and higher
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myelomeningocele, run by Superior University at 1 site in Pakistan.
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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
self administered questioner (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2025.