Evaluating a device to predict preterm birth risk in pregnant women
Official title: Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study
Run by Ultrasound-Innovation Medtech, S.L. · NCT06968364 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 457 (estimated) |
| Sponsor | Ultrasound-Innovation Medtech, S.L. Industry-sponsored |
| Locations | 14 sites (A Coruña and 13 other locations) |
| Status | Recruiting |
| Started | May 10, 2025 |
| Main results expected | February 15, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT06968364 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies have shown promise in using cervical measurements to predict preterm birth, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
H. Universitario de Basurto
Bilbao, Spain Recruiting -
H. Universitario de Cruces
Bilbao, Spain Recruiting -
H. Universitario San Cecilio
Granada, Spain Recruiting -
H. Universitario de Torrejón
Madrid, Spain Recruiting -
H. Universitario de A Coruña
A Coruña, Spain Not yet recruiting -
H. Clínic de Barcelona
Barcelona, Spain Not yet recruiting
Show 8 more locations
-
H. Sant Joan de Déu
Barcelona, Spain Not yet recruiting -
H. Vall d'Hebron
Barcelona, Spain Not yet recruiting -
H. Universitario de Donostia
Donostia / San Sebastian, Spain Not yet 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 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
- Email: alberto.maroto@innitius.com
- Phone: +34 747 44 15 38
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Monitoring blood glucose in pregnant women receiving betamethasone for fetal lung development
This study looks at how the medication betamethasone affects blood sugar levels in pregnant women who don't have diabetes but are at risk of preterm birth.
-
Predictive test for preterm birth in threatened preterm labor
A test called Premaquick is being tried to see if it can better predict preterm delivery in pregnant people with threatened preterm labor.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.