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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.
The study titled "Evaluation of the safety and the preterm birth predictive capacity of the clinical investigation device 'Cervisense TPTL': an international clinical study" is designed to assess both the safety and performance of the Cervisense TPTL device in predicting spontaneous preterm birth. It is being conducted across various Gynaecology, Obstetrics, and Emergency Services in hospitals throughout Spain and Germany.
Cervisense TPTL is the investigational product being evaluated. It includes two components: the Cervisense Intravaginal Probe V0.1, which measures cervical stiffness, and the Fine Birth algorithm, which combines the measurement with clinical data to assess the short-term risk of spontaneous preterm labor.
The device is intended for use in pregnant women showing symptoms of threatened preterm labor (TPTL), with intact amniotic membranes and a single fetus, between 28 weeks and 36 weeks plus 6 days of gestation. Its purpose is to determine the risk of spontaneous preterm birth within the following 7 days.
The clinical investigation is structured in two phases. The pilot study is a randomized, dual-arm, open-label, interventional, multi-centre study conducted in Spain. Participants are randomized 1:1 to receive either the standard of care or the Cervisense evaluation. The pivotal study is non-randomized and single-arm, also open-label and interventional, conducted at a larger scale across multiple centres in both Spain and Germany.
The main goal is to confirm that the device is safe to use and reliable in clinical settings. For safety, all adverse events associated with the use of the device are documented and analyzed in terms of severity, duration, and required intervention. Special attention is given to potential complications such as tissue trauma or infection. To ensure unbiased evaluation, a Clinical Events Committee and a Data Safety Monitoring Board have been established to independently review adverse events and guide study continuation.
Inclusion Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervisense | Experimental | Cervisense arm: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. |
|
| Control arm (only in Pilot Phase) | Active Comparator | Control arm: Cervicometry measured with transvaginal ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. | Device | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ≥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. | From enrollment until delivery |
| 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. | From enrollment until delivery |
| Technical problems ratio (Pilot Phase) | To report less than 10 technical problems that impeded the physician from performing cervical stiffness measurements | From enrollment until the use of the device |
| Probe repeatability (Pilot Phase) | To have an average repeatability rate greater than 75% | From enrollment until the use of the device |
| Valid measurements obtained (Pilot Phase) | To achieve more than 80% of valid cases among the measures obtained | From enrollment until the use of the device |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment until the 14-days follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women with singleton gestation between 28w+0d and 36w+6d.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Maroto Ferrer | Contact | +34 747 44 15 38 | alberto.maroto@innitius.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Universitario de A Coruña | Not yet recruiting | A Coruña | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3945433 | Background | Papiernik E, Bouyer J, Collin D, Winisdoerffer G, Dreyfus J. Precocious cervical ripening and preterm labor. Obstet Gynecol. 1986 Feb;67(2):238-42. doi: 10.1097/00006250-198602000-00014. | |
| 21465603 | Background | Parra-Saavedra M, Gomez L, Barrero A, Parra G, Vergara F, Navarro E. Prediction of preterm birth using the cervical consistency index. Ultrasound Obstet Gynecol. 2011 Jul;38(1):44-51. doi: 10.1002/uog.9010. |
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| Transvaginal ultrasound | Device | Cervicometry measured with transvaginal ultrasound |
|
| 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. | From enrollment until the 14-days follow-up |
| 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. | From enrollment until the use of the device |
| 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. | From enrollment until delivery |
| Subgroup analysis (gestational age, obstetric history) (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 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. | From enrollment until delivery |
| Training performance (Pivotal Phase) | To evaluate the performance of the device in different subgroups (gestational age, previous pregnancies, previous deliveries previous miscarriages, previous episode of TPTL). | From enrollment until delivery |
| Operator satisfaction (SUS) (Pilot and Pivotal Phases) | To measure the operator degree of satisfaction with the Cervisense technique with the SUS (System Usability Scale). | From enrollment until the use of the device |
| Comparison with PartoSure and cervical length (at 7, 10, 14 days) (Pivotal Phase) | To compare the Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) of Cervisense TPTL with the ones obtained with PartoSure test and cervical length within the next 7, 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. | From enrollment until delivery |
| Degree of success obtained during the use of the Cervisense Intravaginal Probe (Pilot Phase) | To measure the degree of success obtained during the use of Cervisense Intravaginal Probe V0.1: device ID, operator profile and code, number of repetitions, % repeatability of the measurement, incidents and probe cover breakage | From enrollment until the use of the device |
| H. Clínic de Barcelona | Not yet recruiting | Barcelona | Spain |
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| H. Sant Joan de Déu | Not yet recruiting | Barcelona | Spain |
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| H. Vall d'Hebron | Not yet recruiting | Barcelona | Spain |
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| H. Universitario de Basurto | Recruiting | Bilbao | Spain |
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| H. Universitario de Cruces | Recruiting | Bilbao | Spain |
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| H. Universitario de Donostia | Not yet recruiting | Donostia / San Sebastian | Spain |
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| H. Universitario San Cecilio | Recruiting | Granada | Spain |
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| H. Materno Infantil de Gran Canaria | Not yet recruiting | Las Palmas de Gran Canaria | Spain |
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| H. General Universitario Gregorio Marañón | Not yet recruiting | Madrid | Spain |
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| H. Universitario de Torrejón | Recruiting | Madrid | Spain |
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| H. Universitario La Paz | Not yet recruiting | Madrid | Spain |
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| H. Universitario de Málaga | Not yet recruiting | Málaga | Spain |
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| H. Virgen Arrixaca | Not yet recruiting | Murcia | Spain |
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| 37094638 | Background | Molina FS, Pardo L, Munoz MD, Aiartzaguena A, Valladolid A, Blanco JE, Burgos J, Gil MM. Reproducibility and usability assessment of the novel Fine Birth device for threatened preterm labor diagnosis. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100982. doi: 10.1016/j.ajogmf.2023.100982. Epub 2023 Apr 23. |
| 28850753 | Background | Melchor JC, Navas H, Marcos M, Iza A, De Diego M, Rando D, Melchor I, Burgos J. Predictive performance of PAMG-1 vs fFN test for risk of spontaneous preterm birth in symptomatic women attending an emergency obstetric unit: retrospective cohort study. Ultrasound Obstet Gynecol. 2018 May;51(5):644-649. doi: 10.1002/uog.18892. Epub 2018 Mar 26. |
| 29920825 | Background | Melchor JC, Khalil A, Wing D, Schleussner E, Surbek D. Prediction of preterm delivery in symptomatic women using PAMG-1, fetal fibronectin and phIGFBP-1 tests: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Oct;52(4):442-451. doi: 10.1002/uog.19119. Epub 2018 Sep 4. |
| 31344796 | Background | Masso P, Callejas A, Melchor J, Molina FS, Rus G. In Vivo Measurement of Cervical Elasticity on Pregnant Women by Torsional Wave Technique: A Preliminary Study. Sensors (Basel). 2019 Jul 24;19(15):3249. doi: 10.3390/s19153249. |
| 1731287 | Background | Jackson GM, Ludmir J, Bader TJ. The accuracy of digital examination and ultrasound in the evaluation of cervical length. Obstet Gynecol. 1992 Feb;79(2):214-8. doi: 10.3109/01443619209013646. |
| 30817303 | Background | Horinouchi T, Yoshizato T, Muto M, Fujii M, Kozuma Y, Shinagawa T, Morokuma S, Kakuma T, Ushijima K. Gestational age-related changes in shear wave speed of the uterine cervix in normal pregnancy at 12-35 weeks' gestation. J Perinat Med. 2019 May 27;47(4):393-401. doi: 10.1515/jpm-2018-0250. |
| 2047066 | Background | Holcomb WL Jr, Smeltzer JS. Cervical effacement: variation in belief among clinicians. Obstet Gynecol. 1991 Jul;78(1):43-5. |
| 8677060 | Background | Goldenberg RL, Mercer BM, Meis PJ, Copper RL, Das A, McNellis D. The preterm prediction study: fetal fibronectin testing and spontaneous preterm birth. NICHD Maternal Fetal Medicine Units Network. Obstet Gynecol. 1996 May;87(5 Pt 1):643-8. doi: 10.1016/0029-7844(96)00035-x. |
| 23836486 | Background | Carlson LC, Feltovich H, Palmeri ML, Dahl JJ, Munoz del Rio A, Hall TJ. Estimation of shear wave speed in the human uterine cervix. Ultrasound Obstet Gynecol. 2014 Apr;43(4):452-8. doi: 10.1002/uog.12555. Epub 2014 Mar 12. |
| 31349721 | Background | Callejas A, Gomez A, Faris IH, Melchor J, Rus G. Kelvin-Voigt Parameters Reconstruction of Cervical Tissue-Mimicking Phantoms Using Torsional Wave Elastography. Sensors (Basel). 2019 Jul 25;19(15):3281. doi: 10.3390/s19153281. |
| 14199536 | Background | BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available. |