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.
Female ≥18 years
Singleton pregnancy
Live fetus, 28w+0d-36w+6d GA
Intact membranes
Latex allergy
Prolapsed membranes
Fetal malformation
Fetal infection
Single group
Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.
DeviceThe Cervisense Intravaginal Probe V0.1 measures cervical stiffness. It is an in-vivo predictive technology that, by using torsional waves, quantifies the mechanical properties (specifically the shear modulus, or resistance of the cervix to shear deformation (kPa), of cervical tissue with extremely high precision. Torsional wave is a type of mechanical wave characterized by a rotational motion and low energy levels (it uses 1000 times less energy than other mechanical waves such as ultrasound). These waves propagate through the tissue, and their propagation speed, which is related to the stiffness (waves propagate faster in stiffer tissues), is measured using piezoelectric sensors.
Transvaginal ultrasound
DeviceCervicometry measured with transvaginal ultrasound
≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)
It will be determined in terms of accuracy, specifically with Specificity and Sensitivity as primary endpoints. Cervisense TPTL will be considered effective in screening for preterm birth risk if the validation study demonstrates at least 90% Specificity and 50% Sensitivity in detecting spontaneous preterm birth within the next 7 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labor (TPTL) presenting to the emergency department.
Document and analyse all adverse events related to device use (severity, duration, intervention) (Pilot and Pivotal Phases)
To document and analyse all adverse events related to the device use, categorized by severity, duration, and required intervention. Exhaustive monitoring of complications directly attributable to the device or its usage, such as tissue damage or active infection.
Technical problems ratio (Pilot Phase)
To report less than 10 technical problems that impeded the physician from performing cervical stiffness measurements
Probe repeatability (Pilot Phase)
To have an average repeatability rate greater than 75%
Monitor labour progression indicators (Pilot and Pivotal Phases)
To monitor key indicators of labour progression, such as frequency and intensity of contractions, and foetal descent after using the device to determine based on clinical criteria if there are any significant changes in labour progression indicators that could be attributed to its use.
Monitor trauma indicators (e.g., petechiae, bleeding) (Pilot and Pivotal Phases)
To monitor key indicators of potential trauma caused by the device entering the vagina or contacting the cervix, such as bruising (petechiae) or bleeding. Visual evaluation of the vagina and the cervix will be performed before and immediately after the use of the device and any significant changes that could be attributed to its use will be documented.
VAS pain score ≤3 (mild/no pain) (Pilot and Pivotal Phases)
To achieve a VAS score attributed to the use of Cervisense Intravaginal Probe V0.1 m≤ 3, which is equivalent to mild or no pain.
Specificity, Sensitivity, PPV, NPV within 10 and 14 days (Pivotal Phase)
To estimate and report Cervisense TPTL Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) in screening for spontaneous preterm birth within the next 10 and 14 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labour (TPTL) presenting to the emergency department.
Click on the lead sponsor to view all of their trials.
