Evaluating a device to predict preterm birth risk in pregnant women

Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study

This study is testing a new device to see if it can help predict the risk of preterm birth in pregnant women who are having early labor symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 457 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Ultrasound-Innovation Medtech, S.L. (Industry-sponsored)
• Locations: 14 sites (A Coruña and 13 other locations)
• Trial ID: NCT06968364 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and predictive capability of the Cervisense TPTL device in identifying the risk of spontaneous preterm birth in pregnant women experiencing threatened preterm labor. The study includes a randomized pilot phase conducted in Spain, followed by a pivotal phase that will be conducted internationally. Participants will undergo an intravaginal measurement of cervical stiffness, and their outcomes will be monitored for 14 days post-assessment to evaluate the device's effectiveness and safety. The study is designed to provide insights into the device's technical reliability and predictive performance in a hospital setting.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18 and older, with a singleton pregnancy between 28 and 36 weeks of gestation, experiencing symptoms of threatened preterm labor.

Not a fit: Patients with certain conditions such as severe vaginal bleeding, fetal malformations, or a history of preterm birth may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve the ability to predict spontaneous preterm births, potentially leading to better management and outcomes for at-risk pregnancies.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using cervical measurements to predict preterm birth, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Where this trial is running

A Coruña and 13 other locations

• 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)

Study contacts

• Study coordinator: Alberto Maroto Ferrer

Conditions Threatened Preterm Labor