Status:
RECRUITING
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
Lead Sponsor:
Ultrasound-Innovation Medtech, S.L.
Conditions:
Threatened Preterm Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
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 s...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT06968364
Start Date
May 10 2025
End Date
April 1 2027
Last Update
May 13 2025
Active Locations (14)
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1
H. Universitario de A Coruña
A Coruña, Spain
2
H. Clínic de Barcelona
Barcelona, Spain
3
H. Sant Joan de Déu
Barcelona, Spain
4
H. Vall d'Hebron
Barcelona, Spain