Sacral MyelomeningocelePRIUM2NCT04770805
In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM
A study testing Fetoscopy in people with Sacral Myelomeningocele and Neural Tube Defects, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sacral Myelomeningocele, Neural Tube Defects, Spina Bifida
- What is being tested?
- Fetoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2021to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- Surgical or anesthetic contraindication.
- Participation in another interventional research protocol,
- Patients under legal protection (guardianship, curatorship).
- Allergies to drugs used in the research
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Myelomeningocele and Myelic limited dorsal myeloschisis (MyeLDM) correspond to neural tube defects which lead to lifelong disabilities including lower extremity paralysis, sphincters deficiency, and cerebral complications (Chiari 2 malformation and hydrocephalus). It is demonstrated that fetal surgery repair of MMC with upper limit between the first thoracic vertebra (T1) and the first sacral vertebra (S1) improves motor and cerebral prognosis. Nowadays, this fetal surgery is performed either after maternal laparotomy and hysterotomy (open fetal surgery) or using fetoscopy. the investigators, at Trousseau Hospital (APHP, Paris), initiated an open fetal surgery of MMC program called PRIUM1 and 16 fetuses has been currently operated.
Fetoscopic repair of MMC is proposed by several international groups in order to prevent from maternal and obstetric morbidity related to the hysterotomy and improve the mother's obstetrical prognosis by allowing vaginal delivery. Results of fetoscopic MMC repair are very satisfying, both in terms of repair surgery efficacy and in terms of obstetrical prognosis. The research team believe that it is justified to propose this minimally invasive repair technique using fetoscopy, for represented by sacral MMC (level S1 and lower) as well as for intermediate forms between open and closed dysgraphisms, represented by MyeLDM. Indeed, these dysraphism are associated with the same cerebral complications than MMC with upper limit between T1 and S1 which could be corrected with prenatal repair. In addition, the spinal cord protection offered by prenatal surgery could prevent from the neuroepithelium destruction observed during pregnancy, with a potential motor benefit for the children.
The main objective of PRIUM 2 is to evaluate the success of fetoscopic surgical repair of sacral MMC or MyeLDM with a birth after 32 weeks of gestation and without severe perinatal morbidity and mortality.
The secondary objectives of PRIUM 2 are to evaluate the complications of pregnancy related to fetoscopic surgery as well as to evaluate the prenatal and postnatal evolution of the cerebral complications (Chiari 2 malformation and hydrocephalus) after fetoscopic repair surgery of the dysraphism (up to 12 months of age).
In this protocol, fetal sacral MMC/ MyeLDM repair surgery will be performed using gas fetoscopy before 26 weeks. After an exteriorization of the uterus through a laparotomy, humidified and warmed gas will be insufflated with low pressure (6 to 8mmHg mmHg). Fetoscopic repair surgery will be performed by a multidisciplinary team (maternal fetal medicine specialists, pediatric neurosurgeons, pediatric surgeons).
After discharge, patients will be followed weekly by a midwife and every two weeks by a referring obstetrician who will perform a clinical examination and a fetal ultrasound.A post procedure MRI will be performed 4 weeks after the surgery. If there is no obstetrical contraindication, vaginal delivery will be authorized.
The children will be followed according to the conventional management of children with dysraphisms and consultations at 8 weeks of life and 12 months of life will be scheduled at Trousseau Hospital, with the multidisciplinary team (pediatric neurosurgeons, physical medicine and rehabilitation specialists, pediatric orthopedic surgeons). During these two consultations, the children will have a complete clinical examination, a cerebral and spinal MRI and an ultrasound of the urinary tract.
- Conditions
- Sacral Myelomeningocele, Neural Tube Defects, Spina Bifida
- Being tested
- Fetoscopy
- Keywords
- Sacral Myelomeningocele, MyeLDM, Fetal surgery, Fetoscopic Repair Program, Neural Tube Defect, Spina bifida
- Medical subject headings
- Neural Tube Defects, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FetoscopyProcedure or surgery
After an exteriorization of the uterus through a laparotomy, humidified and warmed gas will be insufflated with low pressure (6 to 8mmHg mmHg). Fetoscopic repair surgery will consist in a dissection of the placode, its reintegration into the spinal canal and the closure of the lesion, through a three ports access. After fetal surgery, the gas will be exsufflated and the trocar ports will be closed. The uterus will be reintegrated before suturing the maternal abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopic repair | Experimental | Sacral Myelomeningocele and Mye-LDM Fetoscopic repair Receives: Procedure: Fetoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality
Successful complete closure of the defect using the fetoscopic technique AND birth after 32 weeks without severe perinatal morbidity and mortality including grade III-IV intra ventricular hemorrhage, severe, cerebral parenchyma hemorrhage, periventricular leukomalacia, grade III ulcero-necrotizing enterocolitis, severe bronchodysplasia)
Measured: From time of surgery to 8 weeks of life (up to 28 weeks)
Secondary outcomes (22)
Adverse Maternal outcome
diagnosis of maternal gas embolism, hemorrhage, thromboembolic complication, death
Measured: during the surgery
Maternal obstetric outcome as evidenced by preterm labor leading to delivery at less than 37 weeks of gestation
Preterm labor occuring at any time from surgery leading to delivery before 37 weeks of gestation
Measured: From time of surgery until 37 weeks of gestation
Maternal obstetric outcome as evidenced by preterm premature rupture of membranes
Preterm premature rupture of membranes occuring at any time from surgery until 37 weeks of gestation
Measured: From time of surgery until 37 weeks of gestation
Maternal obstetric outcome as evidenced by chorioamnionitis
chorioamnionitis occuring at any time from surgery until 37 weeks of gestation
Measured: From time of surgery until 37 weeks of gestation
Maternal obstetric outcome as evidenced by antenatal betamethasone treatment
indication for a betamethasone course occuring at any time from surgery until 34 weeks of gestation
Measured: From time of surgery until 34 weeks of gestation
Other Maternal obstetric outcome as evidenced by hypertensive disorders, preeclampsia, gestational diabetes
hypertensive disorders, preeclampsia, gestational diabetes occuring any time from surgery until 37 weeks of gestation
Measured: From time of surgery until 37 weeks of gestation
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair
Difference in the growth of the cephalic perimeter measured on an axial ultrasound section
Measured: From time of surgery until birth
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (1)
Difference in measurement of the ventricles on an axial ultrasound section
Measured: From time of surgery until birth
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (2)
Difference in the measurement of the large retro-cerebellar cistern on an axial section of the posterior fossa
Measured: From time of surgery until birth
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (3)
Proportion of patients with reversal of hindbrain herniation (i.e. lower limit of the vermis located above the foramen magnum on ultrasound and/or fetal MRI)
Measured: From time of surgery until birth
Maternal obstetric outcome as evidenced by gestational age at delivery (1)
Gestational age of delivery regardless of indication
Measured: From time of surgery until delivery
Maternal obstetric outcome as evidenced by gestational age at delivery (2)
Proportion of deliveries before 37 weeks of gestation
Measured: From time of surgery until delivery
Maternal obstetric outcome as evidenced by the ability to deliver vaginally
Mode of delivery - either vaginal or cesarean section
Measured: From time of surgery until delivery
Proportion of postpartum hemorrhages
Maternal obstetric outcome as evidenced by postpartum hemorrhage Proportion of postpartum hemorrhages defined by blood loss of more than 500mL for vaginal delivery, and 800mL for cesarean delivery
Measured: From time of surgery until delivery
Need for maternal transfusion (number of blood cells transfused)
Maternal obstetric outcome as evidenced by postpartum hemorrhage Need for maternal transfusion (number of blood cells transfused)
Measured: From time of surgery until delivery
Adverse neonatal outcome at birth (1)
Normal or abnormal birth parameters at birth depending on the term
Measured: at birth
Adverse neonatal outcome at birth (2)
Proportion of fetal asphyxia (arterial pH at the umbilical cord <7.00)
Measured: at birth
Adverse early childhood outcome as evidenced by need for a neurosurgical intervention
need for one of the following neurosurgery
- Type 1: Superficial skin recovery surgery due to scar dehiscence
- Type 2: Need for surgical correction involving all aspects, without reopening the dura
- Type 3: Need for complete surgical correction with repair of the dural plane
Measured: From the time of birth until 8 weeks of life
Postnatal evolution of brain abnormalities associated with open dysraphism
Difference in the growth of the cephalic perimeter by measuring the cranial perimeter between birth and the age of 12 months
Measured: From the time of birth until 12 months of life
Postnatal evolution of brain abnormalities associated with open dysraphism (1)
Difference in the measurement of the cerebral lateral ventricles measured during postnatal transfrontanellar ultrasound followed by cerebral MRI ,
Measured: From the time of birth until 12 months of life
Postnatal evolution of brain abnormalities associated with open dysraphism (2)
Proportion of patients with reversal of hindbrain herniation (i.e. lower limit of the vermis located above the foramen magnum on cerebral MRI)
Measured: From the time of birth until 12 months of life
Postnatal evolution of brain abnormalities associated with open dysraphism (3)
Proportion of patients requiring a cerebrospinal fluid shunt within the first 12 months of life
Measured: From the time of birth until 12 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start16 Apr 2021
- Primary completion24 Nov 2024
- Study completion8 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral MyelomeningoceleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm clinical study. All participants will undergo laparotomy with exteriorization of the uterus followed by fetoscopic repair of the fetal MMC/MyeLDM lesion.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie GUILBAUD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770805
- Sponsor's protocol ID
- APHP191101
- Other IDs
- N° IDRCB: 2020-A01413-36
- Acronym
- PRIUM2
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM
- ClinicalTrials.gov ID
- NCT04770805
- Acronym / sponsor ID
- PRIUM2 / APHP191101
- Conditions
- Sacral Myelomeningocele, Neural Tube Defects, Spina Bifida
- Keywords
- Sacral Myelomeningocele, MyeLDM, Fetal surgery, Fetoscopic Repair Program, Neural Tube Defect, Spina bifida
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 8 Dec 2025 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Myelomeningocele and Myelic limited dorsal myeloschisis (MyeLDM) correspond to neural tube defects which lead to lifelong disabilities including lower extremity paralysis, sphincters deficiency, and cerebral complications (Chiari 2 malformation and hydrocephalus). It is demonstrated that fetal surgery repair of MMC with upper limit between the first thoracic vertebra (T1) and the first sacral vertebra (S1) improves motor and cerebral prognosis. Nowadays, this fetal surgery is performed either after maternal laparotomy and hysterotomy (open fetal surgery) or using fetoscopy. the investigators, at Trousseau Hospital (APHP, Paris), initiated an open fetal surgery of MMC program called PRIUM1 and 16 fetuses has been currently operated.
Fetoscopic repair of MMC is proposed by several international groups in order to prevent from maternal and obstetric morbidity related to the hysterotomy and improve the mother's obstetrical prognosis by allowing vaginal delivery. Results of fetoscopic MMC repair are very satisfying, both in terms of repair surgery efficacy and in terms of obstetrical prognosis. The research team believe that it is justified to propose this minimally invasive repair technique using fetoscopy, for represented by sacral MMC (level S1 and lower) as well as for intermediate forms between open and closed dysgraphisms, represented by MyeLDM. Indeed, these dysraphism are associated with the same cerebral complications than MMC with upper limit between T1 and S1 which could be corrected with prenatal repair. In addition, the spinal cord protection offered by prenatal surgery could prevent from the neuroepithelium destruction observed during pregnancy, with a potential motor benefit for the children.
The main objective of PRIUM 2 is to evaluate the success of fetoscopic surgical repair of sacral MMC or MyeLDM with a birth after 32 weeks of gestation and without severe perinatal morbidity and mortality.
The secondary objectives of PRIUM 2 are to evaluate the complications of pregnancy related to fetoscopic surgery as well as to evaluate the prenatal and postnatal evolution of the cerebral complications (Chiari 2 malformation and hydrocephalus) after fetoscopic repair surgery of the dysraphism (up to 12 months of age).
In this protocol, fetal sacral MMC/ MyeLDM repair surgery will be performed using gas fetoscopy before 26 weeks. After an exteriorization of the uterus through a laparotomy, humidified and warmed gas will be insufflated with low pressure (6 to 8mmHg mmHg). Fetoscopic repair surgery will be performed by a multidisciplinary team (maternal fetal medicine specialists, pediatric neurosurgeons, pediatric surgeons).
After discharge, patients will be followed weekly by a midwife and every two weeks by a referring obstetrician who will perform a clinical examination and a fetal ultrasound.A post procedure MRI will be performed 4 weeks after the surgery. If there is no obstetrical contraindication, vaginal delivery will be authorized.
The children will be followed according to the conventional management of children with dysraphisms and consultations at 8 weeks of life and 12 months of life will be scheduled at Trousseau Hospital, with the multidisciplinary team (pediatric neurosurgeons, physical medicine and rehabilitation specialists, pediatric orthopedic surgeons). During these two consultations, the children will have a complete clinical examination, a cerebral and spinal MRI and an ultrasound of the urinary tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm clinical study. All participants will undergo laparotomy with exteriorization of the uterus followed by fetoscopic repair of the fetal MMC/MyeLDM lesion.
| Arm | Type | Receives |
|---|---|---|
| Fetoscopic repair | Experimental | Procedure: FetoscopySacral Myelomeningocele and Mye-LDM Fetoscopic repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FetoscopyAfter an exteriorization of the uterus through a laparotomy, humidified and warmed gas will be insufflated with low pressure (6 to 8mmHg mmHg). Fetoscopic repair surgery will consist in a dissection of the placode, its reintegration into the spinal canal and the closure of the lesion, through a three ports access. After fetal surgery, the gas will be exsufflated and the trocar ports will be closed. The uterus will be reintegrated before suturing the maternal abdominal wall. | Procedure or surgery | Fetoscopic repair |
Primary outcome
Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality
Time frame: From time of surgery to 8 weeks of life (up to 28 weeks)
Successful complete closure of the defect using the fetoscopic technique AND birth after 32 weeks without severe perinatal morbidity and mortality including grade III-IV intra ventricular hemorrhage, severe, cerebral parenchyma hemorrhage, periventricular leukomalacia, grade III ulcero-necrotizing enterocolitis, severe bronchodysplasia)
22 secondary outcomes
Adverse Maternal outcome
Time frame: during the surgery
Maternal obstetric outcome as evidenced by preterm labor leading to delivery at less than 37 weeks of gestation
Time frame: From time of surgery until 37 weeks of gestation
Maternal obstetric outcome as evidenced by preterm premature rupture of membranes
Time frame: From time of surgery until 37 weeks of gestation
Maternal obstetric outcome as evidenced by chorioamnionitis
Time frame: From time of surgery until 37 weeks of gestation
Maternal obstetric outcome as evidenced by antenatal betamethasone treatment
Time frame: From time of surgery until 34 weeks of gestation
Other Maternal obstetric outcome as evidenced by hypertensive disorders, preeclampsia, gestational diabetes
Time frame: From time of surgery until 37 weeks of gestation
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair
Time frame: From time of surgery until birth
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (1)
Time frame: From time of surgery until birth
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (2)
Time frame: From time of surgery until birth
Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (3)
Time frame: From time of surgery until birth
Maternal obstetric outcome as evidenced by gestational age at delivery (1)
Time frame: From time of surgery until delivery
Maternal obstetric outcome as evidenced by gestational age at delivery (2)
Time frame: From time of surgery until delivery
Maternal obstetric outcome as evidenced by the ability to deliver vaginally
Time frame: From time of surgery until delivery
Proportion of postpartum hemorrhages
Time frame: From time of surgery until delivery
Need for maternal transfusion (number of blood cells transfused)
Time frame: From time of surgery until delivery
Adverse neonatal outcome at birth (1)
Time frame: at birth
Adverse neonatal outcome at birth (2)
Time frame: at birth
Adverse early childhood outcome as evidenced by need for a neurosurgical intervention
Time frame: From the time of birth until 8 weeks of life
Postnatal evolution of brain abnormalities associated with open dysraphism
Time frame: From the time of birth until 12 months of life
Postnatal evolution of brain abnormalities associated with open dysraphism (1)
Time frame: From the time of birth until 12 months of life
Postnatal evolution of brain abnormalities associated with open dysraphism (2)
Time frame: From the time of birth until 12 months of life
Postnatal evolution of brain abnormalities associated with open dysraphism (3)
Time frame: From the time of birth until 12 months of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie GUILBAUD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopy in people with Sacral Myelomeningocele and Neural Tube Defects, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality (time frame: From time of surgery to 8 weeks of life (up to 28 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.