Open Spina Bifida Fetoscopic Repair Project

NCT03562286 | Unknown DMC

• 1 other identifier: Estudio No.414
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelomeningocele

Keywords

Open spina bifida; spinal dysraphism

Outcome Measures

Primary Outcomes (1)

• Capability to achieve successful closure of the myelomeningocele by fetoscopic surgery

  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.

  Time of procedure (day 0)

Secondary Outcomes (8)

• Surgery time (minutes)

  Time of procedure in minutes (day of surgery / day 0)

• Delivery gestational age (weeks and days)

  From surgery and up to 21 weeks after the procedure

• Premature rupture of membranes PROM (weeks and days)

  Between the surgery to 37 weeks of pregnancy (18 weeks after repair)

• Chorioamnionitis

  Between the surgery and delivery (up to 20 weeks after repair)

• Mode of delivery

  Delivery, up to 21 weeks after surgery

Study Arms (1)

Experimental Fetoscopy

EXPERIMENTAL

All participants will undergo fetoscopic repair of open spina bifida

Procedure: Fetoscopy

Interventions

Fetoscopy PROCEDURE

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.

Also known as: Fetal surgery

Experimental Fetoscopy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women with singleton pregnancy and fetus with myelomeningocele with the upper boundary located between T1 and S1
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Pregnant women - maternal age 18 years old or older and capable of consenting for their own participation in the study
• \- Singleton pregnancy
• \- Myelomeningocele with the upper boundary located between T1 and S1
• \- Evidence of hindbrain herniation (confirmed on MRI) to have Arnold Chiari type II malformation)
• \- Absence of chromosomal abnormalities and associated anomalies.
• \- Gestational age at the time of the procedure will be between 19 to 26 weeks
• \- 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.

You may not qualify if:

• \- Fetal anomaly unrelated to myelomeningocele
• \- Sever kyphosis
• \- Increased risk for preterm labor included short cervical length (\<15 mm), history of incompetent cervix with or without cerclage, and previous preterm birth
• \- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• \- A prepregnancy body mass index \> or equal to 35 Kg/m2
• \- 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.
• \- Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, and uterine anomalies.
• \- Maternal fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• \- Maternal HIV, Hepatitis B/C status positive
• \- Maternal medical condition that is a contraindication to surgery or anesthesia

Sponsors & Collaborators

• Medicina Perinatal Alta Especialidad, México: lead
• Universidad de Monterrey: collaborator

Study Sites (1)

Hospital Christus Muguerza Alta Especialidad

Monterrey, Nuevo León, Mexico

RECRUITING

MeSH Terms

Conditions

Meningomyelocele; Spina Bifida Cystica; Spinal Dysraphism

Interventions

Fetoscopy

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Fetal Therapies; Therapeutics; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures

Central Study Contacts

Gerardo Sepúlveda González, MD

CONTACT

52 (81) 83351606; gerardo_sepulveda@hotmail.com

Iván V Dávila Escamilla, MD

CONTACT

52 (81) 81230894; ivanvladimir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fetal Surgery Coordinator Hospital Christus Muguerza Alta Especialidad

Model Details: Intervention model: single group assignment Masking: None (Open label) Primary purpose: treatment

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: June 19, 2018
• Study Start: October 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)