NCT03315637

Brief Summary

This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

7 years

First QC Date

October 3, 2017

Last Update Submit

October 16, 2017

Conditions

Neural Tube DefectsSpina Bifida, OpenMyelomeningoceleFetal DiseaseHydrocephalusChiari Malformation Type 2Congenital AbnormalitySurgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus

Outcome Measures

Primary Outcomes (1)

  • Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)

    Binary variable (yes/no) describing if the neural tube defect has been successfully closed, (placode 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 (3)

  • Operating time (minutes)

    Time of procedure (day 0)

  • Fetoscopy time (minutes)

    Time of procedure (day 0)

  • Hospital stay (days)

    Between procedure and delivery, up to 21 weeks

Other Outcomes (15)

  • Post-operative hemoglobin (g/dL)

    24 hours after procedure

  • Blood transfusion (yes/no)

    Between procedure and discharge, up to 21 weeks

  • Gestational age at delivery (weeks and days as x/7)

    At birth, up to 21 weeks after procedure

  • +12 more other outcomes

Study Arms (1)

Fetoscopic repair of spina bifida

EXPERIMENTAL

This is a single arm study, all patients will receive a fetoscopic repair of the spina bifida

Procedure: Fetoscopic repair of spina bifida

Interventions

Fetoscopic repair of spina bifidaPROCEDURE

Fetoscopic intrauterine repair of open spina bifida

Fetoscopic repair of spina bifida

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age \> 18 years old
  • Singleton pregnancy
  • Gestational age between 18 0/7 weeks and 26 6/7 weeks
  • Isolated neural tube defect between T1 and S1
  • Cerebellar herniation (Chiari type II)

You may not qualify if:

  • Fetal anomalies non related to neural tube defect (NTD) including chromosomal abnormalities
  • Body mass index \> 35 kg/m2
  • Maternal disorders contraindicating surgery
  • Genetic anomalies with poor prognosis
  • Sever kyphosis (\>30º)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (2)

  • Maroto A, Illescas T, Melendez M, Arevalo S, Rodo C, Peiro JL, Belfort M, Cuxart A, Carreras E. Ultrasound functional evaluation of fetuses with myelomeningocele: study of the interpretation of results. J Matern Fetal Neonatal Med. 2017 Oct;30(19):2301-2305. doi: 10.1080/14767058.2016.1247262. Epub 2017 Jan 16.

    PMID: 27997256BACKGROUND

  • Belfort MA, Whitehead WE, Shamshirsaz AA, Bateni ZH, Olutoye OO, Olutoye OA, Mann DG, Espinoza J, Williams E, Lee TC, Keswani SG, Ayres N, Cassady CI, Mehollin-Ray AR, Sanz Cortes M, Carreras E, Peiro JL, Ruano R, Cass DL. Fetoscopic Open Neural Tube Defect Repair: Development and Refinement of a Two-Port, Carbon Dioxide Insufflation Technique. Obstet Gynecol. 2017 Apr;129(4):734-743. doi: 10.1097/AOG.0000000000001941.

    PMID: 28277363BACKGROUND

MeSH Terms

Conditions

Neural Tube DefectsSpina Bifida CysticaMeningomyeloceleFetal DiseasesHydrocephalusArnold-Chiari MalformationCongenital Abnormalities

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSpinal DysraphismPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBrain DiseasesCentral Nervous System Diseases

Central Study Contacts

Elena Carreras, PhD

CONTACT

ecarreras@vhebron.net

Nerea Maiz, PhD

CONTACT

nmaiz@vhebron.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 20, 2017

Study Start

January 1, 2015

Primary Completion

December 31, 2021

Study Completion

December 31, 2024

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

ES(1)