Fetoscopic Repair of Isolated Fetal Spina Bifida
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03090633|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 23, 2017
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)|
|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|
All participants will undergo fetoscopic repair of fetal spina bifida.
Minimally invasive in-utero surgery
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090633
|Contact: Jena Miller, MDemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21202|
|Contact: Jena Miller, MD 410-502-6561 firstname.lastname@example.org|
|Sub-Investigator: Ahmet Baschat, MD|
|Sub-Investigator: Edward Ahn, MD|
|Sub-Investigator: Jamie Murphy, MD|
|Principal Investigator:||Jena Miller, MD||Johns Hopkins University|