New Biomarkers Associated With the Risk of Premature Delivery. (NCT04067908) | Clinical Trial Compass
TerminatedNot Applicable
New Biomarkers Associated With the Risk of Premature Delivery.
Stopped: target number of subjects not reached
111 participantsStarted 2011-06-07
Plain-language summary
Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality.
This study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth.
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:
* Pregnant women over 18 years of age
* Term from 22 to 33 and 6 amenorrhea weeks
* Single or twin pregnancy
* Emergency consultant, in participating centers, for a threat of premature labor defined by:
Uterine contractions greater than or equal to 3 in 30 minutes Clinical modification of the cervix Ultrasound collar less than 25 mm
* Free, informed and written consent, dated and signed by the patient and the investigator before any investigation required by the research.
* Patient affiliated to a Social Security scheme.
Exclusion Criteria:
* Premature rupture of membranes
* Placenta previa
* Vaginal haemorrhage at the time of sampling
* Uterine malformation
* Strapping, open bite
* History of strapping and or open bite
* Conization
* Fetal malformation
* Associated vasorenal pathology
* Sexual intercourse less than 24h
* Gynecological examination less than 48h
* Vaginal treatment in progress
* Polyhydramnios
* Transfused-transfused syndrome
* Twin Anemia Polycythemia syndrome
* Fetoscopy during pregnancy
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
Premature delivery yes/no
Timeframe: Premature delivery before 33 amenorrhea weeks + 6 days