FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study

NCT06968364 | Recruiting DMC

• 1 other identifier: FB-CT2
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Threatened Preterm Labor

Outcome Measures

Primary Outcomes (5)

• ≥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

Secondary Outcomes (9)

• Monitor labour progression indicators (Pilot and Pivotal Phases)

  From enrollment until the 14-days follow-up

• Monitor trauma indicators (e.g., petechiae, bleeding) (Pilot and Pivotal Phases)

  From enrollment until the 14-days follow-up

• VAS pain score ≤3 (mild/no pain) (Pilot and Pivotal Phases)

  From enrollment until the use of the device

• Specificity, Sensitivity, PPV, NPV within 10 and 14 days (Pivotal Phase)

  From enrollment until delivery

• Subgroup analysis (gestational age, obstetric history) (Pivotal Phase)

  From enrollment until delivery

Study Arms (2)

Cervisense

EXPERIMENTAL

Cervisense arm: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.

Device: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.

Control arm (only in Pilot Phase)

ACTIVE COMPARATOR

Control arm: Cervicometry measured with transvaginal ultrasound

Device: Transvaginal ultrasound

Interventions

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.

Cervisense

Transvaginal ultrasound DEVICE

Cervicometry measured with transvaginal ultrasound

Control arm (only in Pilot Phase)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women with singleton gestation between 28w+0d and 36w+6d.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female ≥18 years
• Singleton pregnancy
• Live fetus, 28w+0d-36w+6d GA
• Intact membranes
• Cervical dilatation \<2 cm
• Signed informed consent
• Regular uterine contractions (≥8/60 min) (Pivotal only)

You may not qualify if:

• Latex allergy
• Prolapsed membranes
• Fetal malformation
• Fetal infection
• Vaginal bleeding (severe or persistent)
• Cervical cerclage
• Müllerian anomalies
• Pessary use
• Regular uterine contractions (reported by patient) (Pilot only)
• History of preterm birth or TPTL (Pilot only)
• Vasa/placenta previa (Pilot only)
• Gastrointestinal or urinary infections (Pivotal only)

Sponsors & Collaborators

• Ultrasound-Innovation Medtech, S.L.: lead

Study Sites (14)

H. Universitario de A Coruña

A Coruña, Spain

NOT YET RECRUITING

H. Clínic de Barcelona

Barcelona, Spain

NOT YET RECRUITING

H. Sant Joan de Déu

Barcelona, Spain

NOT YET RECRUITING

H. Vall d'Hebron

Barcelona, Spain

NOT YET RECRUITING

H. Universitario de Basurto

Bilbao, Spain

RECRUITING

H. Universitario de Cruces

Bilbao, Spain

RECRUITING

H. Universitario de Donostia

Donostia / San Sebastian, Spain

NOT YET RECRUITING

H. Universitario San Cecilio

Granada, Spain

RECRUITING

H. Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Spain

NOT YET RECRUITING

H. General Universitario Gregorio Marañón

Madrid, Spain

NOT YET RECRUITING

H. Universitario de Torrejón

Madrid, Spain

RECRUITING

H. Universitario La Paz

Madrid, Spain

NOT YET RECRUITING

H. Universitario de Málaga

Málaga, Spain

NOT YET RECRUITING

H. Virgen Arrixaca

Murcia, Spain

NOT YET RECRUITING

Related Publications (13)

• 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.

  PMID: 3945433 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.

  PMID: 21465603 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.

  PMID: 37094638 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.

  PMID: 28850753 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.

  PMID: 29920825 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.

  PMID: 31344796 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.

  PMID: 1731287 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.

  PMID: 30817303 BACKGROUND

• Holcomb WL Jr, Smeltzer JS. Cervical effacement: variation in belief among clinicians. Obstet Gynecol. 1991 Jul;78(1):43-5.

  PMID: 2047066 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.

  PMID: 8677060 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.

  PMID: 23836486 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.

  PMID: 31349721 BACKGROUND

• BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.

  PMID: 14199536 BACKGROUND

Central Study Contacts

Alberto Maroto Ferrer

CONTACT

+34 747 44 15 38; alberto.maroto@innitius.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

ES (14)