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Fetoscopic Repair for Spina Bifida (fMMC Trial)
fMMC Trial Summary
This trial will help researchers understand if a new, minimally invasive technique for repairing fetal MMC is feasible and as effective as traditional surgery, but with less risks for mother and baby.
fMMC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowfMMC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.fMMC Trial Design
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Who is running the clinical trial?
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- You have a condition that could harm your baby during this pregnancy.I have a health condition that makes surgery or anesthesia unsafe for me.My family and I have decided against ending the pregnancy before 24 weeks.My amniotic fluid is low due to a fetal issue, poor placenta function, or membrane rupture.My genetic tests show no chromosomal abnormalities.My genetic tests from amniocentesis or CVS show normal results, or I have a balanced translocation with no other issues.I have been diagnosed with Arnold-Chiari type II malformation.My spinal condition is between the T1 and S1 vertebrae.You have certain placental issues, like placenta previa, placental abruption, or placenta accreta, at the time of joining the study.I have a severe curvature in my upper back.I cannot have surgery due to a past uterine procedure or condition.The baby has a birth defect not related to MMC.You are pregnant with only one baby.Your BDI-II questionnaire shows that you have very severe depression, with a score of 29 or higher.You have a high chance of giving birth too early, such as having a short cervix or a history of previous preterm birth.I do not have HIV or Hepatitis, or I have tested negative for these before joining.I cannot have fetoscopic surgery due to conditions like uterine fibroids.My BMI was 40 or more before I got pregnant.The mother is allergic to collagen.The procedure is for pregnant people between 19 weeks and 25 weeks.I am a pregnant woman, 18 or older, and can consent for myself.
- Group 1: fetoscopic surgical repair
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are enrollment opportunities available for this experiment currently?
"The information found on clinicaltrials.gov reveals that this trial, initially publicized on July 1st 2014 and recently revised April 2nd 2022 is not presently enrolling patients. Despite no longer recruiting candidates for this study, there are 27 other trials actively seeking participants at the moment."
Does the age requirement for this experiment extend to individuals over fifty-five years old?
"This medical study is specifically tailored for individuals between 18 and 64 years in age. For younger or older patients, there are 15 clinical trials available to those below 18 and 12 options for seniors over 65."
To what extent can fetoscopy be detrimental to a person's health?
"The safety of fetoscopy was assessed as a 1 due to its early stage clinical trials, displaying limited data regarding efficacy and security."
Do I meet the necessary criteria to be a participant in this examination?
"This research endeavour is recruiting 60 subjects with acrania between legal adulthood and retirement age. Mainly, the applicants should fulfill these conditions: be of 18 years or older in order to give consent for participation; free from chromosomal abnormalities and accompanying anomalies; gestation period must span 19 0/7 weeks to 25 6/7 weeks upon procedure commencement; have an adequate amount of social support as well as understanding of the study's requirements; chosen not to terminate pregnancy prior 24 weeks mark."
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