CompletedNot Applicable

Cervical Stiffness Assessment in High-risk Pregnancies for Preterm Birth

Switzerland21 participantsStarted 2023-07-27

Plain-language summary

Cervical length is usually measured using ultrasound, and if it is shortened, hormone therapy (progesterone) is recommended to reduce the risk of premature birth. The investigators want to find out what cervical stiffness is like in women with a shortened cervical length before and during hormone therapy. The investigators believe that this measurement will help to better assess the risk of premature birth in the future.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed consent signed by the participant * Pregnant women more or equal to 18 years of age. * Singleton gestation * Weeks of pregnancy between 16 weeks 0 days and 32 weeks and 0 days * Cervix less or equal to 25 mm (inferior to the 5th centile at 25 wp) * No regular contractions * Planned progesterone treatment Exclusion Criteria: * Cognitively impaired adults * Cerclage or pessary on place * Ongoing progesterone (if continued or started after 13+0 wp) treatment * Multiple pregnancies * Placenta praevia totalis with hemorrhage (irrespective of severity) * Vasa praevia * Light bleeding (if the bleeding can be stopped it is no longer an exclusion criterion) * Heavy vaginal bleeding, hematoma or chorioamniotic membrane separation * Rupture of membranes (exclusion with ROM+ test if PPROM is suspected) * History of cervical surgery only if visible scaring at 12 o'clock * Cervical dilation more equal to 3 cm * Signs of chorioamnionitis * Symptomatic genital infection * Known carrier of HIV or Hepatitis B/C * Fetal malformations

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cervical stiffness index (mbar) at enrollment

Timeframe: 1 day

Trial details

NCT IDNCT07541313

SponsorLuzerner Kantonsspital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-29

View on ClinicalTrials.gov More Cervical Insufficiency trials