Prenatal and Postnatal Ultrasonographic Evaluation of Myelomeningocele to Predict Post-Surgical Outcomes

NCT07048691 | Active Not Recruiting DMC

• 1 other identifier: MSAHSW/Batch-Fall23/909
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelomeningocele

Outcome Measures

Primary Outcomes (1)

• self administered questioner

  self administered questioner for yelomeningocele patients scroing range fron 0-40. 0 is for lower and 40 is worse and higher

  12 Months

Study Arms (1)

G.E HEALTHCARE ultrasound machine with high-resolution convex probe

Diagnostic Test: G.E HEALTHCARE ultrasound machine with high-resolution convex probe

Interventions

G.E HEALTHCARE ultrasound machine with high-resolution convex probe DIAGNOSTIC_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

G.E HEALTHCARE ultrasound machine with high-resolution convex probe

Eligibility Criteria

• Age: 28 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Gestational age 3rd trimester, Lesion between T1 and S1, Hindbrain herniation and Normal karyotype

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Allied Hospital

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: March 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 28, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)