Introduction
We hypothesize that after publication of the quintessence of the MOMS-Trial, eligibility criteria for prenatal spina bifida repair may be modified if a tenable argumentation underlies this decision.
Methods
Our first 154 fetal surgery patients were analyzed with particular focus on how many, which, and why the original eligibility criteria, set forth by the MOMS Trial Protocol, were disobeyed, and what the eventually detectable, negative and positive, impact of these deviations on outcomes was.
Results
A total of 152 patients (2 missing consent) were included (100%). In 69 patients (45.4%), a total of 89 eligibility criteria were disobeyed. In 54 (35.6%) cases, maternal criteria were concerned: Gestational age at operation of >25+6 weeks in 17 (11.2%), uterine pathologies in 13 (8.6%) women, preoperative BMI≥35 kg/m2 in 12 (7.9%), previous hysterotomy in 7 (4.6,%), previous prematurity in 3 (2%), HIV/hepatitis B in 2 (1.3%), psychosocial issues in 2 (1.3%), and placenta praevia in 1 (0.7%). In 32 (21.1%) cases, fetal criteria were disobeyed: Fetal anomaly unrelated to spina bifida in 19 (12.5%), no/minimal evidence of hindbrain herniation in 13 (8.6%), and severe kyphosis in 2 (1.3%).
We could not identify cases where non-observation of criteria led to clear-cut maternal and/or fetal disadvantages.
Conclusion
This study shows that MOMS-Trial eligibility criteria for prenatal spina bifida repair should be modified or even abandoned with adequate medical and ethical argumentation, and with written parental informed consent after non-directive, full disclosure counseling. This clear cut change of paradigm is a necessity as it leads towards personalized medicine allowing more fetuses to benefit from fetal surgery than would have benefitted with the former published MOMS criteria in place.