The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm labor (TPTL), between 28+0 and 36+6 weeks of gestation. The main questions it aims to answer are: Does the Cervisense TPTL device predict spontaneous preterm birth within 7 days? Is the device safe and technically reliable in a hospital setting? Researchers will conduct a Pilot Study (randomized, dual-arm) followed by a Pivotal Study (single-arm) to assess technical feasibility and predictive performance. Participants will undergo an intravaginal measurement of cervical stiffness using the Cervisense Intravaginal Probe. They will be followed for 14 days after the assessment to record delivery outcomes and any adverse events.
Age range
18 Years
Sex
FEMALE
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≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)
Timeframe: From enrollment until delivery
Document and analyse all adverse events related to device use (severity, duration, intervention) (Pilot and Pivotal Phases)
Timeframe: From enrollment until delivery
Technical problems ratio (Pilot Phase)
Timeframe: From enrollment until the use of the device
Probe repeatability (Pilot Phase)
Timeframe: From enrollment until the use of the device
Valid measurements obtained (Pilot Phase)
Timeframe: From enrollment until the use of the device