Cervical Softening and the Prediction of Preterm Birth (NCT05477381) | Clinical Trial Compass
UnknownNot Applicable
Cervical Softening and the Prediction of Preterm Birth
Netherlands390 participantsStarted 2022-08-18
Plain-language summary
Currently, transvaginal cervical length measurement is used to screen in asymptomatic pregnant women with a history of PTB. In symptomatic women, presenting with threatened PTB cervical length in combination with the fibronectin test is used to identify women at high risk to deliver preterm. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.
Cervical softening is precursor of cervical shortening, effacement and dilatation and therefore cervical softening is a promising new marker that is based on tissue elasticity. However, the predictive value of cervical softening and the relation with spontaneous PTB still has to be determined. With the newly developed Pregnolia® System cervical softness could be measured on a standardized and safe manner. This study could help to improve care for women with a history of spontaneous PTB.
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:
* Age 18 years or above.
* Ability to understand Dutch or English (both spoken and written).
* Ultrasound-based gestational age determined by measurement of crown rump length (CRL) determined between 9 and 11 weeks of gestation.
* Singleton and twin pregnancies.
Cohort A-STIPP specific:
\- Medical history of spontaneous preterm birth before 34 weeks of gestation
Cohort S-STIPP specific:
* Threatened Preterm birth between 24 and 34 weeks of gestation.
* Threatened preterm birth is defined as:
* abdominal pain
* (Braxton Hicks) contractions
* vaginal blood loss.
Exclusion Criteria:
* Under 18 years of age.
* Signs of intrauterine infection.
* Obstetric indication for immediate delivery (advanced labor, cord prolapse, abruption, signs of fetal distress).
* Confirmed fetal abnormality.
* Confirmed preterm rupture of membranes.
* Confirmed vasa / placenta praevia.
* Severe vaginal bleeding and light bleeding that cannot be stopped.
* Signs of imminent labor such as blood loss, regular contractions.
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
1
Spontaneous Preterm Birth < 34 weeks
Timeframe: Maximum time frame up to 28 weeks: from inclusion at 14 weeks of gestational age until delivery, with a maximum of 42 weeks of gestational age.
2
Delivery within seven days after inclusion
Timeframe: From inclusion until 7 days later
Trial details
NCT IDNCT05477381
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)