Trial Outcomes & Findings for Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study (NCT NCT03936322)
NCT ID: NCT03936322
Last Updated: 2025-02-24
Results Overview
Total number of maternal adverse events
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
From time of surgery until delivery (up to 21 weeks)
Results posted on
2025-02-24
Participant Flow
Participant milestones
| Measure |
Pregnant Women Diagnosed With Fetal Myelomeningocele
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
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|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Pregnant Women Diagnosed With Fetal Myelomeningocele
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
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|---|---|
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Overall Study
Lost to Follow-up
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1
|
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Overall Study
Infant Death after delivery; therefore, no further follow up occurred
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1
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Baseline Characteristics
Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
Baseline characteristics by cohort
| Measure |
Pregnant Women Diagnosed With Fetal Myelomeningocele
n=3 Participants
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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2 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of surgery until delivery (up to 21 weeks)Total number of maternal adverse events
Outcome measures
| Measure |
Pregnant Women Diagnosed With Fetal Myelomeningocele
n=3 Participants
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
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|---|---|
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Maternal Adverse Events
|
2 participants
|
PRIMARY outcome
Timeframe: From the time of surgery until 28 days of life (up 25 weeks)Total number of neonatal adverse events
Outcome measures
| Measure |
Pregnant Women Diagnosed With Fetal Myelomeningocele
n=3 Participants
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
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|---|---|
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Neonatal Adverse Events
|
1 participants
|
Adverse Events
Pregnant Women Diagnosed With Fetal Myelomeningocele
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregnant Women Diagnosed With Fetal Myelomeningocele
n=3 participants at risk
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
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|---|---|
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Pregnancy, puerperium and perinatal conditions
Placenta abruption/neonatal demise
|
33.3%
1/3 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Pregnant Women Diagnosed With Fetal Myelomeningocele
n=3 participants at risk
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
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|---|---|
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Pregnancy, puerperium and perinatal conditions
premature rupture of the membranes
|
33.3%
1/3 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place