Open Spina Bifida Fetoscopic Repair Project
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|ClinicalTrials.gov Identifier: NCT03562286|
Recruitment Status : Unknown
Verified June 2018 by Gerardo Sepúlveda González, Medicina Perinatal Alta Especialidad, México.
Recruitment status was: Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myelomeningocele||Procedure: Fetoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Intervention model: single group assignment Masking: None (Open label) Primary purpose: treatment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||Open Spina Bifida Fetoscopic Repair Project|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Experimental Fetoscopy
All participants will undergo fetoscopic repair of open spina bifida
Performing a minimally invasive procedure using a fetoscopic technique in order to access to amniotic cavity and make the endoscopic repair of the fetal neural tube defect.
Other Name: Fetal surgery
- Capability to achieve successful closure of the myelomeningocele by fetoscopic surgery [ Time Frame: Time of procedure (day 0) ]Binary variable (yes/no) describing if the neural tube defect (myelomeningocele) has been successfully closed (placed dissected and dropped into the open spinal canal, cystic tissue resected and edges closed to the midline), by fetoscopic surgery, and without conversion to open surgery.
- Surgery time (minutes) [ Time Frame: Time of procedure in minutes (day of surgery / day 0) ]Time between the skin incision and skin closure
- Delivery gestational age (weeks and days) [ Time Frame: From surgery and up to 21 weeks after the procedure ]Gestational age at birth
- Premature rupture of membranes PROM (weeks and days) [ Time Frame: Between the surgery to 37 weeks of pregnancy (18 weeks after repair) ]Amniotic fluid leakage before onset of labor
- Chorioamnionitis [ Time Frame: Between the surgery and delivery (up to 20 weeks after repair) ]The presence or absence of an intrauterine infection
- Mode of delivery [ Time Frame: Delivery, up to 21 weeks after surgery ]Vaginal or cesarean delivery
- Neurodevelopment evaluation by Bayley Scales of infant development II [ Time Frame: Up to 24 months after birth ]Score of the Mental Developmental Index of the Bayley Scales of Infant Development II at 24 months of age. The score ranges from 50 (minimum) to 150 (maximum). A score of <70 indicates severe developmental delay; 70-84 indicates moderate delay; >85 indicates no delay.
- Childhood motor function on physical examination [ Time Frame: 24 months after birth ]Difference between the anatomic upper border of the lesion level and motor function based on the physical examination at 24 months of age. A positive score of 2 indicates a functional level 2 vertebrae higher than lesion level. A score of -2 indicates a function level 2 vertebrae lower than the lesion level.
- Ventriculoperitoneal shunt [ Time Frame: After birth and up to 12 months ]Need for a cerebrospinal fluid shunt within the first year of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562286
|Contact: Gerardo Sepúlveda González, MD||52 (81) email@example.com|
|Contact: Iván V Dávila Escamilla, MD||52 (81) firstname.lastname@example.org|