New device could help predict preterm birth in High-Risk pregnancies
NCT ID NCT07541313
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested a new device that measures cervical stiffness in 21 pregnant women at high risk for preterm birth. The goal was to see if stiffness measurements could improve risk assessment beyond standard ultrasound checks. Researchers hope this could lead to better prediction and management of preterm birth risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a new way to assess preterm birth risk, helping doctors decide who needs treatment.
- What could go wrong
- This was a very small pilot study with only 21 participants, so results may not apply to all women. The device is still experimental.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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21 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
pregnant women
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Luzerner Kantonsspital
Lucerne, Canton of Lucerne, 6000, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a common antibiotic prevent early birth in High-Risk pregnancies?
- Bed rest for short cervix under scrutiny: could normal activity be better?
- Laughing gas tested to take the edge off cerclage removal
- Timing matters: study seeks optimal moment for cervical length check to prevent preterm birth
- Which progesterone works best to stop preterm birth? 820 women studied
- New study tests whether extra support during pregnancy can prevent early delivery