Prediction of Spontaneous Onset of Labor at Term (NCT05109247) | Clinical Trial Compass
CompletedNot Applicable
Prediction of Spontaneous Onset of Labor at Term
Switzerland429 participantsStarted 2019-08-22
Plain-language summary
The study intends to develop a predictive model of spontaneous onset of labor between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date. The main hypothesis is that a combination of clinical, ultrasonographic, biochemical and/or biophysical variables will allow to differentiate women who will spontaneously trigger their labors from those who will require an induction by the term of their pregnancies. A tool of this kind should aid in the individualization of the management of the final weeks of pregnancy and, at the light of recent evidence, provide support to the decision-making processes.
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:
* Alive fetus
* Singletons
* Cephalic presentation
* Intact membranes
* Gestational age ≥ 38 weeks and 5 days
Exclusion Criteria:
* Fetal malformations
* Symptomatic uterine contractions
* Contraindication for vaginal delivery
* Medical indication of induction of labor or elective cesarean delivery
* Maternal desire to induce labor
* Maternal negative to enrollment
* Language barrier
* Inability to give consent
Specific Exclusion Criteria for Pregnolia System (if any of these criteria is present, the measurement of cervical stiffness using Pregnolia aspiration device will not be performed):
* Müllerian anomalies with two cervices
* Severe vaginal bleeding
* Cervical dilatation
* Known HIV
* Visible, symptomatic cervical or vaginal infections
* If one of the following conditions is present on the cervix at the 12 o'clock position:
* Nabothian cyst
* Cervical myomas
* Cervical condylomas
* Squamous intraepithelial lesion
* Conization/LEEP2/LLETZ3
* Cervical endometriosis
* Cervical tears
* Cervical dysplasia
* Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
* Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present.
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.