Active — Not RecruitingNot Applicable

In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM

France10 participantsStarted 2021-04-16

Plain-language summary

The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital (Paris, France).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion Criteria : * Pregnant women age 18 years and older who are able to consent * Singleton pregnancy before 26 weeks of gestation, * Sacral MMC (upper level S1 or below) or MyeLDM diagnosed on ultrasound and MRI, 4. Absence of associated malformation apart from the anomalies usually observed in cases of open dysraphisms (i.e. feet malpositions, associated cerebral signs) or chromosomal anomaly if verification of the karyotype was desired by the couple * Affiliated to health insurance, understanding and speaking French * Written consent of the patient for the surgery and representatives of the parental authority for the postnatal follow-up of the child * Patient who made the choice to continue the pregnancy Exclusion Criteria: * Abnormal angulation of the fetal spine, * risk factors for prematurity: cervical length less \< 15mm, history of late miscarriage before 22 weeks, pre-existing rupture of the membranes at inclusion, * Placenta praevia, * BMI greater than 35 kg / m2, * Abnormality of the uterus: large fibroid, uterine malformation, history of uterine body surgery * Maternal infection at risk of maternal-fetal transmission: HIV, HBV, HCV, * Surgical or anesthetic contraindication. * Participation in another interventional research protocol, * Patients under legal protection (guardianship, curatorship). * Allergies to drugs used in the research

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality

Timeframe: From time of surgery to 8 weeks of life (up to 28 weeks)

Trial details

NCT IDNCT04770805

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-24

View on ClinicalTrials.gov More Sacral Myelomeningocele trials