Response to Moldenhauer, Johnson & Van Mieghem ISPD 2022 DEBATE: There should be formal accreditation and ongoing quality assurance/review for units offering fetal therapy that includes public reporting of outcomes. MFAET, an international standardised medical terminology to support quality assurance/review for units offering fetal therapy

Summary: The field of fetal therapy lacks formal accreditation and quality control, but published evidence suggests that outcomes in younger centers are comparable to more experienced ones and interventions have improved over time. Publication bias and lack of randomized controlled trials pose challenges in setting standards of care. Collaborative networks and large registries help benchmark center outcomes and track rare complications, aiding in improving patient outcomes. Formal accreditation, quality control, and outcome reporting are difficult and costly to implement and may limit access to care for smaller centers.

Summary: This study aimed to improve safety monitoring for developing pregnancy drugs, devices, and interventions by creating AE terminology. An international multidisciplinary group filled gaps in definitions and severity grading through a modified Delphi process, allowing systematic consistent AE assessment in pregnancy trials.