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
Recruiting
N/A
Interventional Study
Threatened Preterm Labor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 457 (estimated)
- Sponsor
- Ultrasound-Innovation Medtech, S.L. · Industry
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About This Trial
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 withi…
Trial Locations
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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 malform…
Contacts