CompletedNot Applicable

Prenatal Endoscopic Repair of Fetal Spina Bifida

France7 participantsStarted 2017-05-17

Plain-language summary

The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

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: * Patient \> 18 years old, with an assumption by health insurance, understanding and speaking French * A term \< or = 26 +0 weeks gestational age * Single-Pregnancy * Myelomeningocele with higher-level defect between S1 and T1 * Arnold Chiari anomaly * No associated anomaly or chromosic anomaly Exclusion Criteria: * severe foetal kyphoscoliosis associated * Increased risk of preterm birth: cervical length \<15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane * placenta previa, accreta or placental abruption * Maternal obesity with BMI\> 35 * Uterine anomalies : large interstitial uterine fibroid, uterine malformation * maternal infection with a foetal transmission risk: HIV, HBV, HCV * Maternal contradiction in surgery or anesthesia * poor social status and/or social isolation * impossible post-surgery follow-up * want to have a medical pregnancy termination

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

Successful surgery

Timeframe: Before 26 gestational weeks

Neonatal surgery

Timeframe: Day 0 (birth of neonates)

Arnold Chiari anomaly at birth

Timeframe: Day 0 (birth of neonates)

Ventriculo-peritoneal shunt

Timeframe: Within the 6 months after birth

Level of injury

Timeframe: Within the 6 months after birth

Foetal morbidity

Timeframe: From surgery to delivery

Motor lower limb improvement outcomes

Timeframe: Within the 6 months after birth

Maternal morbidity

Timeframe: From surgery to delivery

Trial details

NCT IDNCT02390895

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-06

View on ClinicalTrials.gov More Myelomeningocele trials

Plain-language summary

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.

What they're measuring

Successful surgery

Timeframe: Before 26 gestational weeks

Neonatal surgery

Timeframe: Day 0 (birth of neonates)

Arnold Chiari anomaly at birth

Timeframe: Day 0 (birth of neonates)

Ventriculo-peritoneal shunt

Timeframe: Within the 6 months after birth

Level of injury

Timeframe: Within the 6 months after birth

Foetal morbidity

Timeframe: From surgery to delivery

Motor lower limb improvement outcomes

Timeframe: Within the 6 months after birth

Maternal morbidity

Timeframe: From surgery to delivery