Identification of Spontaneous Delivery Markers (NCT02225717) | Clinical Trial Compass
CompletedNot Applicable
Identification of Spontaneous Delivery Markers
France238 participantsStarted 2014-12-14
Plain-language summary
The investigators project aims to identify, in pregnant women, discriminating molecules to allow an early detection of women who will spontaneously deliver prematurely, suitable in routine clinical practice.
Human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and fetal membranes (the water bag) remodelling. Precocious remodelling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not.
In this regard, remodelled fetal membranes overlying the cervix may discharge signals that could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.
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:
\- Singleton pregnancy, monitored in Port Royal or secondarily transferred, between 24 and 32 GA. Hospitalization for preterm labor (cervix \< 25 mm at transvaginal cervical ultrasound) or -Singleton pregnancy, monitered in Port Royal between 15-16 weeks of gestation, without complication.
or - Singleton pregnancy, monitered in Port Royal between 35-36 weeks of gestation, without complication.
or - Healthy woman, no pregnancy.
Exclusion Criteria:
* Minor
* Not affiliated to health insurance
* Persons under guardianship or judicial protection
* Infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
* Diabetes or chronic inflammatory disease
* Carrier of B streptococcus
* Cervical strapping
* Fetus with chromosomal abnormalities
* Infections
* Premature rupture of membrane
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.