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Open Spina Bifida Fetoscopic Repair Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Universidad de Monterrey
Information provided by (Responsible Party):
Gerardo Sepúlveda González, Medicina Perinatal Alta Especialidad, México

Brief Summary:
The aim of the study is to assess a new fetal surgery approach to repair open spina bifida. The fetal group hypothesis is to perform a minimally invasive procedure using a fetoscopic technique in order to access to amniotic cavity and make the endoscopic repair. This approach will allow investigators to make the closure of the defect and avoid the use of an hysterotomy, reducing the risk of maternal complications as uterine dehiscence (rupture), hemorrhage and preterm premature rupture of membranes (PPROM), the patient also will be able to have a vaginal delivery.

Condition or disease Intervention/treatment Phase
Myelomeningocele Procedure: Fetoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Fetoscopy
All participants will undergo fetoscopic repair of open spina bifida
Procedure: Fetoscopy
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Surgery time (minutes) [ Time Frame: Time of procedure in minutes (day of surgery / day 0) ]
    Time between the skin incision and skin closure

  2. Delivery gestational age (weeks and days) [ Time Frame: From surgery and up to 21 weeks after the procedure ]
    Gestational age at birth

  3. 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

  4. Chorioamnionitis [ Time Frame: Between the surgery and delivery (up to 20 weeks after repair) ]
    The presence or absence of an intrauterine infection

  5. Mode of delivery [ Time Frame: Delivery, up to 21 weeks after surgery ]
    Vaginal or cesarean delivery

  6. 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.

  7. 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.

  8. Ventriculoperitoneal shunt [ Time Frame: After birth and up to 12 months ]
    Need for a cerebrospinal fluid shunt within the first year of life



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women with singleton pregnancy and fetus with myelomeningocele with the upper boundary located between T1 and S1
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. - Pregnant women - maternal age 18 years old or older and capable of consenting for their own participation in the study
  2. - Singleton pregnancy
  3. - Myelomeningocele with the upper boundary located between T1 and S1
  4. - Evidence of hindbrain herniation (confirmed on MRI) to have Arnold Chiari type II malformation)
  5. - Absence of chromosomal abnormalities and associated anomalies.
  6. - Gestational age at the time of the procedure will be between 19 to 26 weeks
  7. - Normal karyotype and / or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or CVS). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded.

Exclusion Criteria:

  1. - Fetal anomaly unrelated to myelomeningocele
  2. - Sever kyphosis
  3. - Increased risk for preterm labor included short cervical length (<15 mm), history of incompetent cervix with or without cerclage, and previous preterm birth
  4. - Placental abnormalities (previa, abruption, accreta) known at time of enrollment
  5. - A prepregnancy body mass index > or equal to 35 Kg/m2
  6. - Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, mayor myomectomy resection or previous fetal surgery) in active uterine segment.
  7. - Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, and uterine anomalies.
  8. - Maternal fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
  9. - Maternal HIV, Hepatitis B/C status positive
  10. - Maternal medical condition that is a contraindication to surgery or anesthesia

Information from the National Library of Medicine

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


Contacts
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Contact: Gerardo Sepúlveda González, MD 52 (81) 83351606 gerardo_sepulveda@hotmail.com
Contact: Iván V Dávila Escamilla, MD 52 (81) 81230894 ivanvladimir@hotmail.com

Locations
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Mexico
Hospital Christus Muguerza Alta Especialidad Recruiting
Monterrey, Nuevo Leon, Mexico
Contact: Gerardo Sepúlveda González, MD    +52 (81) 83351606    gerardo_sepulveda@hotmail.com   
Contact: Iván V Dávila Escamilla, MD    52 (81) 81230894    ivanvladimir@hotmail.com   
Sponsors and Collaborators
Medicina Perinatal Alta Especialidad, México
Universidad de Monterrey
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Responsible Party: Gerardo Sepúlveda González, Fetal Surgery Coordinator Hospital Christus Muguerza Alta Especialidad, Medicina Perinatal Alta Especialidad, México
ClinicalTrials.gov Identifier: NCT03562286    
Other Study ID Numbers: Estudio No.414
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gerardo Sepúlveda González, Medicina Perinatal Alta Especialidad, México:
Open spina bifida
spinal dysraphism
Additional relevant MeSH terms:
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Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities