An interventional study of Minimally invasive fetoscopic repair of MMC in Spina Bifida, Myelomeningocele and Neural Tube Defects, sponsored by Rodrigo Ruano. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Rodrigo Ruano · Not applicable, Interventional, and Treatment
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's enrollment of 3 is below the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →Rodrigo Ruano is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
MMC diagnosis with the upper boundary located between Thoracic 1 (T1) and Sacral
1 (S1).
Exclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Maternal Adverse Events
Total number of maternal adverse events
Time frame: From time of surgery until delivery (up to 21 weeks)
Neonatal Adverse Events
Total number of neonatal adverse events
Time frame: From the time of surgery until 28 days of life (up 25 weeks)
| Milestone | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| Started | 3 |
| Completed | 1 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Infant death after delivery; therefore, no further follow up occurred | 1 |
Total number of maternal adverse events
| participants | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| Maternal Adverse Events | 2 |
Total number of neonatal adverse events
| participants | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| Neonatal Adverse Events | 1 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregnant Women Diagnosed With Fetal Myelomeningocele | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) |
| Event | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| Placenta abruption/neonatal demisePregnancy, puerperium and perinatal conditions | 1/3 |
| Event | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| premature rupture of the membranesPregnancy, puerperium and perinatal conditions | 1/3 |
| Age, Categorical(Participants) | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| Female | 3 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Jun 2024, 61 months.
Results were first posted in Feb 2025, 7 months after primary completion.
Of 60 non-industry interventional studies with no phase under Spinal Dysraphism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's 61 months is above that.
Counting every sponsor, half of 62 studies reached it within 31 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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