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Fetoscopic Repair of Isolated Fetal Spina Bifida

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ClinicalTrials.gov Identifier: NCT03090633
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

The purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital.

The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the same effectiveness as open repair of fetal spina bifida, but with the benefit of significantly lower maternal and fetal complication rates. The fetal benefit of the procedure will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida repair will be the avoidance of a large uterine incision. This type of incision increases the risk of uterine rupture and requires that all future deliveries are by cesarean section. The use of the minimally invasive fetoscopic surgical technique may also lower the risk of preterm premature rupture of membranes and preterm birth compared to open fetal surgery. Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.


Condition or disease Intervention/treatment Phase
Spina Bifida Myelomeningocele Chiari Malformation Type 2 Neural Tube Defects Spinal Dysraphism Congenital Abnormality Device: Fetoscopy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm clinical study. All participants will undergo laparotomy with exteriorization of the uterus followed by minimally-invasive, fetoscopic repair of the fetal spina bifida lesion.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Fetoscopic Repair of Myelomeningocele in Fetuses With Isolated Spina Bifida
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2027


Arm Intervention/treatment
Experimental: Fetoscopy
All participants will undergo fetoscopic repair of fetal spina bifida.
Device: Fetoscopy
Minimally invasive in-utero surgery
Other Names:
  • Karl Storz Endoscopy America, Inc.
  • Richard Wolf Medical Instruments, Corp.
  • Cook Medical, Inc.
  • Pare Surgical, Inc.




Primary Outcome Measures :
  1. Ability to perform fetoscopic spina bifida repair [ Time Frame: From time of surgery until delivery (up to 21 weeks) ]
    Successful complete closure of the defect fetoscopically and reversal of hindbrain herniation on ultrasound and MRI prior to delivery


Secondary Outcome Measures :
  1. Maternal obstetric outcome as evidenced by preterm premature rupture of membranes [ Time Frame: From time of surgery until 37 weeks of gestation (up to 18 weeks) ]
    Preterm premature rupture of membranes occuring any time from surgery until 37 weeks of gestation

  2. Maternal obstetric outcome as evidenced by preterm labor leading to delivery at less than 34 weeks of gestation [ Time Frame: From time of surgery until 34 weeks of gestation (up to 15 weeks) ]
    Preterm labor occuring at any time from surgery leading to delivery before 34 weeks of gestation

  3. Maternal obstetric outcome as evidenced by gestational age at delivery [ Time Frame: From time of surgery until delivery (up to 21 weeks) ]
    Gestational age of delivery regardless of indication

  4. Maternal obstetric outcome as evidenced by the ability to delivery vaginally [ Time Frame: From time of surgery until delivery (up to 21 weeks) ]
    Mode of delivery - either vaginal or cesarean section

  5. Adverse fetal or neonatal outcome as evidenced by fetal or neonatal death [ Time Frame: From the time of surgery until 28 days of life (up 25 weeks) ]
    Composite of fetal or neonatal death

  6. Adverse early childhood outcome as evidenced by need for a cerebrospinal fluid shunt [ Time Frame: From the time of birth until 12 months of life ]
    Need for a cerebrospinal fluid shunt within the first year of life

  7. Neurodevelopmental outcome as evaluated by the Bayley Scales of Infant Development II [ Time Frame: 30 months of age ]
    Score of the Mental Developmental Index of the Bayley Scales of Infant Development II at 30 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.

  8. Early childhood motor function on physical examination [ Time Frame: 30 months of age ]
    Difference between the anatomic upper border of the lesion level and motor function based on the physical examination at 30 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This is a study of pregnant women.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women age 18 years and older who are able to consent
  • Singleton pregnancy
  • Normal fetal karyotype
  • Isolated fetal spina bifida with the upper lesion level between T1-S1
  • Gestational age between 19+0 to 25+6 weeks gestation

Exclusion Criteria:

  • Pregnant women less than 18 years of age
  • Multiple gestation
  • Fetal anomaly unrelated to spina bifida
  • Maternal contraindication to fetoscopic surgery
  • Severe maternal medical condition in pregnancy
  • Technical limitations preluding fetoscopic surgery
  • Preterm labor
  • Cervical length < 25mm
  • Placenta previa
  • Psychosocial ineligibility precluding consent
  • Maternal Beck Depression Inventory score ≥ 17

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): NCT03090633


Contacts
Contact: Jena Miller, MD 410-502-6561 jmill260@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21202
Contact: Jena Miller, MD    410-502-6561    jmill260@jhmi.edu   
Sub-Investigator: Ahmet Baschat, MD         
Sub-Investigator: Edward Ahn, MD         
Sub-Investigator: Jamie Murphy, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Jena Miller, MD Johns Hopkins University

Publications of Results:
Other Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03090633     History of Changes
Other Study ID Numbers: IRB00123834
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Johns Hopkins University:
Fetoscopy
Fetal surgery
Fetal spina bifida

Additional relevant MeSH terms:
Congenital Abnormalities
Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Arnold-Chiari Malformation
Nervous System Malformations
Nervous System Diseases