Actively 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
Led by Ultrasound-Innovation Medtech, S.L. · Updated on 2025-05-13
457
Participants Needed
14
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female 18 years or older
- Singleton pregnancy
- Live fetus between 28 weeks 0 days and 36 weeks 6 days gestation
- Intact membranes
- Cervical dilation less than 2 cm
- Signed informed consent
- Regular uterine contractions of 8 or more per 60 minutes (Pivotal study only)
You will not qualify if you...
- Allergy to latex
- Prolapsed membranes
- Fetal malformation
- Fetal infection
- Severe or persistent vaginal bleeding
- Cervical cerclage
- Mullerian anomalies
- Use of pessary
- Regular uterine contractions reported by patient (Pilot study only)
- History of preterm birth or threatened preterm labor (Pilot study only)
- Vasa previa or placenta previa (Pilot study only)
- Gastrointestinal or urinary infections (Pivotal study only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
H. Universitario de A Coruña
A Coruña, Spain
Not Yet Recruiting
2
H. Clínic de Barcelona
Barcelona, Spain
Not Yet Recruiting
3
H. Sant Joan de Déu
Barcelona, Spain
Not Yet Recruiting
4
H. Vall d'Hebron
Barcelona, Spain
Not Yet Recruiting
5
H. Universitario de Basurto
Bilbao, Spain
Actively Recruiting
6
H. Universitario de Cruces
Bilbao, Spain
Actively Recruiting
7
H. Universitario de Donostia
Donostia / San Sebastian, Spain
Not Yet Recruiting
8
H. Universitario San Cecilio
Granada, Spain
Actively Recruiting
9
H. Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Spain
Not Yet Recruiting
10
H. General Universitario Gregorio Marañón
Madrid, Spain
Not Yet Recruiting
11
H. Universitario de Torrejón
Madrid, Spain
Actively Recruiting
12
H. Universitario La Paz
Madrid, Spain
Not Yet Recruiting
13
H. Universitario de Málaga
Málaga, Spain
Not Yet Recruiting
14
H. Virgen Arrixaca
Murcia, Spain
Not Yet Recruiting
Research Team
A
Alberto Maroto Ferrer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
2
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