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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00385-40 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No prenatal surgical repair of myelomeningocele | |
| Case - open surgical repair | Experimental | Prenatal surgical repair of fetal myelomeningocele |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prenatal surgical repair of fetal myelomeningocele | Procedure | open surgical repair of myelomeningocele before 26 weeks gestational age |
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| Measure | Description | Time Frame |
|---|---|---|
| Arnold Chiari anomaly at birth | the existence of an Arnold Chiari anomaly at birth | 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) | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Zerah, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Jean-Marie Jouannic, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Armand Trousseau, APHP | Paris | PARIS | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26566108 | Result | 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. | |
| 33915336 |
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| ID | Term |
|---|---|
| D008591 | Meningomyelocele |
| D001139 | Arnold-Chiari Malformation |
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| Guilbaud 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |