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

NCT ID: NCT07048691

Last Updated: 2025-07-02

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

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-02-28

Brief Summary

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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

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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

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Myelomeningocele

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

Intervention Type 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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Allied Hospital

Faisalābad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSAHSW/Batch-Fall23/909

Identifier Type: -

Identifier Source: org_study_id

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