RecruitingNot ApplicableNCT03856034

Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study

Sponsor

USFetus

Enrollment

12 participants

Start Date

Nov 2, 2018

Study Type

INTERVENTIONAL

Conditions

Myelomeningocele Spina Bifida Neural Tube Defects Chiari Malformation

Summary

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a minimally invasive fetoscopic (keyhole) surgery technique to repair myelomeningocele — a serious form of spina bifida where the spinal cord protrudes through an opening in the back — while the baby is still in the womb. Two approaches are compared: a fully percutaneous (through-the-skin) method for mothers with a posterior placenta, and a laparotomy (small abdominal incision) approach available to all participants. Pregnant women aged 18 and older between 19 and 27 weeks of gestation carrying a baby with confirmed myelomeningocele and hindbrain herniation, without other fetal abnormalities, and who can remain near the participating hospital for the rest of the pregnancy, are eligible. Participation involves fetal surgery with follow-up visits at 12, 24, 30, 48, and 60 months after the baby's birth to assess neurological and developmental outcomes. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFetoscopy

Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).