Foetus With MyelomeningocelePRIUMNCT01983345
Prenatal Surgical Repair of Fetal Myelomeningocele
A study testing prenatal surgical repair of fetal myelomeningocele in people with Foetus With Myelomeningocele, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one corresponding to the anatomical defect (as… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Foetus With Myelomeningocele
- What is being tested?
- prenatal surgical repair of fetal myelomeningocele
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2014to 28 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- patient of majority age, with an assumption by health insurance, understanding and speaking French
- A term between 19 and 25 +6 weeks gestational age (not for control)
- Single-Pregnancy
- Normal fetal karyotype
- Myelomeningocele with higher-level defect between S1 and T1
- Placenta not low-inserted or not covering
- Fault-isolated ultrasound reference
Who cannot join
- Age under 18 years
- Patient foreigner who understands not French
- Multiple Pregnancy
- Low Placenta inserted or covering
- Severe kyphosis
- Placental abruption
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- Fetal malformation unrelated to the existence of myelomeningocele (the existence of a malposition of one or both feet do not represent an exclusion criterion)
- Increased risk of preterm birth: a history of preterm delivery before 37 weeks gestational age, cervical length <26 mm before 26 weeks gestational age (not for control)
- Bleeding active between 20 and 26 weeks gestational age (not for control)
- Maternal obesity with BMI> 35 (not for control)
- History of uterine surgery involving the anterior surface of the uterus (not for control)
- Maternal contradiction in surgery or general anesthesia (not for control)
Trial locations and contacts
1 site in 1 country.
About this study
The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one corresponding to the anatomical defect (as defined by the last upper normal vertebra before the defect).
The purpose of this study is to introduce in France an innovative technique for prenatal repair of myelomeningocele until now developed only on the American continent.
Read the detailed description
Spina bifida (SB) represents one of the most severe congenital malformation of the central nervous system and amenable to prenatal diagnosis. In the past 20 years, prenatal repair of SB has become an established technique.
The PRIUM study will include 10 cases of fetuses with prenatal diagnosis of SB and for whom the maternal willing will be to continue the pregnancy. A surgical prenatal repair of the defect will be planed at 19-25+6 weeks gestation following maternal laparotomy and hysterotomy under maternal general anesthesia. The delivery will be planed at 36 weeks'. Postnatal evaluation of the neonates will be scheduled at birth, 1 month, 12 months and 36 months of age. Those data will be matched to controls who have underwent a conventional postnatal repair of the SB
- Conditions
- Foetus With Myelomeningocele
- Being tested
- prenatal surgical repair of fetal myelomeningocele
- Keywords
- Myelomeningocele, Arnold Chiari malformation, Spina bifida
- Medical subject headings
- Meningomyelocele, Arnold-Chiari Malformation, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prenatal surgical repair of fetal myelomeningoceleProcedure or surgery
open surgical repair of myelomeningocele before 26 weeks gestational age
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No prenatal surgical repair of myelomeningocele |
| Case - open surgical repair | Experimental | Prenatal surgical repair of fetal myelomeningocele Receives: Procedure: prenatal surgical repair of fetal myelomeningocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arnold Chiari anomaly at birth
the existence of an Arnold Chiari anomaly at birth
Measured: Day 0
Defect
the level difference between the observed level of injury and the anatomical level of the defect (as defined by the last normal upper vertebra before the defect)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start10 Jul 2014
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Foetus With 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Michel Zerah, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisJean-Marie Jouannic, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983345
- Sponsor's protocol ID
- P121103
- Other IDs
- 2013-A00385-40
- Acronym
- PRIUM
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2013
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Friszer S, Dhombres F, Di Rocco F, Rigouzzo A, Garel C, Guilbaud L, Forin V, Moutard ML, Zerah M, Jouannic JM. [Preliminary results from the French study on prenatal repair for fetal myelomeningoceles (the PRIUM study)]. J Gynecol Obstet Biol Reprod (Paris). 2016 Sep;45(7):738-44. doi: 10.1016/j.jgyn.2015.09.002. Epub 2015 Nov 10. French.
PubMed 26566108Guilbaud L, Maurice P, Lallemant P, De Saint-Denis T, Maisonneuve E, Dhombres F, Friszer S, Di Rocco F, Garel C, Moutard ML, Lachtar MA, Rigouzzo A, Forin V, Zerah M, Jouannic JM. Open fetal surgery for myelomeningocele repair in France. J Gynecol Obstet Hum Reprod. 2021 Nov;50(9):102155. doi: 10.1016/j.jogoh.2021.102155. Epub 2021 Apr 26.
PubMed 33915336
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Surgical Repair of Fetal Myelomeningocele
- ClinicalTrials.gov ID
- NCT01983345
- Acronym / sponsor ID
- PRIUM / P121103
- Conditions
- Foetus With Myelomeningocele
- Keywords
- Myelomeningocele, Arnold Chiari malformation, Spina bifida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Jul 2014 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 14 Nov 2013 (estimated)
- 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 open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one corresponding to the anatomical defect (as defined by the last upper normal vertebra before the defect).
The purpose of this study is to introduce in France an innovative technique for prenatal repair of myelomeningocele until now developed only on the American continent.
Detailed description
Spina bifida (SB) represents one of the most severe congenital malformation of the central nervous system and amenable to prenatal diagnosis. In the past 20 years, prenatal repair of SB has become an established technique.
The PRIUM study will include 10 cases of fetuses with prenatal diagnosis of SB and for whom the maternal willing will be to continue the pregnancy. A surgical prenatal repair of the defect will be planed at 19-25+6 weeks gestation following maternal laparotomy and hysterotomy under maternal general anesthesia. The delivery will be planed at 36 weeks'. Postnatal evaluation of the neonates will be scheduled at birth, 1 month, 12 months and 36 months of age. Those data will be matched to controls who have underwent a conventional postnatal repair of the SB
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No prenatal surgical repair of myelomeningocele |
| Case - open surgical repair | Experimental | Procedure: prenatal surgical repair of fetal myelomeningocelePrenatal surgical repair of fetal myelomeningocele |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patient of majority age, with an assumption by health insurance, understanding and speaking French
- A term between 19 and 25 +6 weeks gestational age (not for control)
- Single-Pregnancy
- Normal fetal karyotype
- Myelomeningocele with higher-level defect between S1 and T1
Key exclusion criteria (12 listed)
- Age under 18 years
- Patient foreigner who understands not French
- Multiple Pregnancy
- Low Placenta inserted or covering
- Severe kyphosis
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 |
|---|---|---|
| prenatal surgical repair of fetal myelomeningoceleopen surgical repair of myelomeningocele before 26 weeks gestational age | Procedure or surgery | Case - open surgical repair |
Primary outcome
Arnold Chiari anomaly at birth
Time frame: Day 0
the existence of an Arnold Chiari anomaly at birth
Defect
Time frame: 3 years
the level difference between the observed level of injury and the anatomical level of the defect (as defined by the last normal upper vertebra before the defect)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 26566108Friszer S, Dhombres F, Di Rocco F, Rigouzzo A, Garel C, Guilbaud L, Forin V, Moutard ML, Zerah M, Jouannic JM. [Preliminary results from the French study on prenatal repair for fetal myelomeningoceles (the PRIUM study)]. J Gynecol Obstet Biol Reprod (Paris). 2016 Sep;45(7):738-44. doi: 10.1016/j.jgyn.2015.09.002. Epub 2015 Nov 10. French.
- Results publication: PubMed 33915336Guilbaud L, Maurice P, Lallemant P, De Saint-Denis T, Maisonneuve E, Dhombres F, Friszer S, Di Rocco F, Garel C, Moutard ML, Lachtar MA, Rigouzzo A, Forin V, Zerah M, Jouannic JM. Open fetal surgery for myelomeningocele repair in France. J Gynecol Obstet Hum Reprod. 2021 Nov;50(9):102155. doi: 10.1016/j.jogoh.2021.102155. Epub 2021 Apr 26.
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.
Michel Zerah, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Jean-Marie Jouannic, MD, PhD 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 prenatal surgical repair of fetal myelomeningocele in people with Foetus With Myelomeningocele, 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Arnold Chiari anomaly at birth (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983345, which also lists 2 linked publications.
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 8 Sep 2025.