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

Launched by ULTRASOUND-INNOVATION MEDTECH, S.L. · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called Cervisense TPTL, which aims to help predict the risk of spontaneous preterm birth in pregnant women who are showing signs of threatened preterm labor. Specifically, the trial is looking at women who are between 28 and 36 weeks pregnant. The main goals are to see if the device can accurately predict whether a woman might give birth within the next week and to ensure that the device is safe and reliable for use in hospitals.

To participate in this trial, women must be at least 18 years old, be pregnant with a single baby, have a live fetus, and show certain symptoms like regular contractions. Participants will undergo a simple test that measures the stiffness of the cervix using a special device. After the test, they will be monitored for 14 days to see what happens with their pregnancy and to check for any side effects. This study is currently recruiting participants, and it’s important for women to discuss with their doctors if they meet the eligibility criteria before considering joining.

Gender

FEMALE

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)