The Lioness™ device: a prospective non-randomized safety and feasibility study of a novel device for preterm birth delay and prevention.

BACKGROUND: Preterm birth is a leading cause of neonatal mortality and morbidity. Existing interventions to reduce preterm birth risk, such as progesterone therapy, cervical cerclage, and the Arabin pessary, demonstrate limited efficacy, particularly in women with twin pregnancies or a history of preterm birth. The Lioness™ is an elastic silicone ring, with six supporting arms and an encompassing band placed around the cervix at the site of the Shirodkar cerclage, promoting cervical elongation and helping to maintain it throughout pregnancy. It aims to reduce the risk of preterm birth by providing mechanical support to the cervix and preventing early cervical shortening. It is designed for non-surgical placement with dedicated application tools, by the physician in the clinic in a few minutes' procedure. OBJECTIVE: To evaluate the functionality of the Lioness™ device among pregnant women at risk of preterm birth, through serial cervical measurements. STUDY DESIGN: This is a secondary analysis of a prospective, non-randomized, open-label, single-arm safety and feasibility study involving participants at risk for preterm birth with either a history of spontaneous preterm birth before the 37th gestational week without cervical insufficiency or a Dichorionic Diamniotic (DCDA) twin pregnancy. The earlier study evaluated Unanticipated Serious Adverse Device Effects (USADE) and patient satisfaction. Given that cervical length is a key predictor of preterm birth, this analysis focused on serial cervical length measurements and safety-related outcomes following Lioness placement. The study was not powered to assess preterm birth incidence. RESULTS: 11 of 12 participants completed the study and 10 of 11 reached term or a few days before term. The study documented only mild and transient adverse events, primarily related to device placement. Initial cervical length measurements taken prior to device placement averaged 42 mm. Following placement, measurements at 20, 24, and 28 weeks of gestation consistently showed an average increase to 49 mm, 49 mm, and 45 mm, respectively. Duration of pregnancy from Lioness™ device placement averaged 142 days (134 to 155 days). CONCLUSIONS: These results indicate a notable trend in cervical elongation associated with the use of the Lioness™ device, suggesting its potential to enhance cervical support during pregnancy. These preliminary findings suggest that the LionessTM could be a promising alternative to existing preterm birth delay and prevention methods, warranting further investigation in a larger trial.