PLUGGING THE GAP: An enabling technology to prevent rupture of fetal membranes in fetal endoscopic surgery

A plug will be developed and clinically evaluated that closes the fetal membranes after endoscopic surgery on unborn babies in a consortium with Radboudumc, ErasmusMC and the company HCM Medical. In addition, various patient organisations (Platform CHD and NVOM) and University Hospital Leuven are involved.

Minimal fetal surgery using endoscopy is a promising medical technology to treat children before birth, e.g. children with rare diseases like congenital diaphragmatic hernia, twin-to-twin transfusion syndrome or spina bifida. During endoscopy, the fetal membranes are punctured, which introduces a risk of membrane rupture (iPPROM: iatrogenic preterm premature rupture of membranes). iPPROM is a strong trigger for premature birth, infection and maternal sepsis, and comes with considerable morbidity and mortality. Fetal membrane defects do not heal spontaneously.

Therefore, the aim is to develop and clinically evaluate a plug that closes the membranes at the endoscopic entry point preventing amniotic fluid leakage and associated severe complications. The estimatation is that closure of the punctured membranes with a plug will lead to 42 less births being premature in the Netherlands per year. As premature birth cost approximately € 70,000 per child per year for the first 18 years of life and the treatment is a relatively cheap medical device only needed during fetoscopic surgery, it could result in a tremendous save in healthcare costs. One year after introduction, a total saving of €3,000,000 is anticipated, which increases to €53,000,000 18 years after introduction.

In the project, the plug will be evaluated in tissue explants, animal models and in clinical trials (Phase 2/Pilot Phase 3). Anticipated is that the plug allows further development of fetal surgery without the high rate of iPPROM.