Fetoscopic Repair of Isolated Fetal Spina Bifida

NCT03090633 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB00123834
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spina Bifida; Myelomeningocele; Chiari Malformation Type 2; Neural Tube Defects; Spinal Dysraphism; Congenital Abnormality

Keywords

Fetoscopy; Fetal surgery; Fetal spina bifida

Outcome Measures

Primary Outcomes (1)

• Ability to perform fetoscopic spina bifida repair

  Successful complete closure of the defect fetoscopically and reversal of hindbrain herniation on ultrasound and MRI prior to delivery

  From time of surgery until delivery (up to 21 weeks)

Secondary Outcomes (8)

• Maternal obstetric outcome as evidenced by preterm premature rupture of membranes

  From time of surgery until 37 weeks of gestation (up to 18 weeks)

• Maternal obstetric outcome as evidenced by preterm labor leading to delivery at less than 34 weeks of gestation

  From time of surgery until 34 weeks of gestation (up to 15 weeks)

• Maternal obstetric outcome as evidenced by gestational age at delivery

  From time of surgery until delivery (up to 21 weeks)

• Maternal obstetric outcome as evidenced by the ability to delivery vaginally

  From time of surgery until delivery (up to 21 weeks)

• Adverse fetal or neonatal outcome as evidenced by fetal or neonatal death

  From the time of surgery until 28 days of life (up 25 weeks)

Study Arms (1)

Fetoscopy

EXPERIMENTAL

All participants will undergo fetoscopic repair of fetal spina bifida.

Device: Fetoscopy

Interventions

Fetoscopy DEVICE

Minimally invasive in-utero surgery

Also known as: Karl Storz Endoscopy America, Inc., Richard Wolf Medical Instruments, Corp., Cook Medical, Inc., Pare Surgical, Inc.

Fetoscopy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: This is a study of pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21202, United States

Location

Related Publications (33)

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  PMID: 21306277 RESULT

• Belfort MA, Whitehead WE, Shamshirsaz AA, Ruano R, Cass DL, Olutoye OO. Fetoscopic Repair of Meningomyelocele. Obstet Gynecol. 2015 Oct;126(4):881-884. doi: 10.1097/AOG.0000000000000835.

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MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele; Arnold-Chiari Malformation; Neural Tube Defects; Congenital Abnormalities

Interventions

Fetoscopy

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; 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

Study Officials

• Ahmet Baschat, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 27, 2017
• Study Start: May 11, 2017
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After execution of the Consortium and Data Base Provider Agreement, PROVIDER shall enter the Limited Data Set to the website maintained by BAYLOR. This Agreement shall terminate when all of the Limited Data Set provided by PROVIDER to BAYLOR for the Permitted Data Use is destroyed.
• Access Criteria: The Data Base will be accessible by all Consortium members.

Locations

US (1)