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New treatment option for Preterm Labor
Official title Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
ClinicalTrials.gov ID: NCT05586334
What this study is testing
What is Collection of vaginal secretions?
Collection of vaginal secretions is an investigational medicine, being studied as a potential treatment for preterm labor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to clinically validate the predictive performance (sensitivity and specificity) of the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in the target population of women consulting obstetric emergencies for preterm labor (PTL).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant with live fetus(es)
- Emergency room visit between 22 and 34 days of pregnancy + 6 days
- For a suspicion of PTL defined by :
- Uterine contractions (UC) objectified during the consultation (questioning, clinical examination, external tocography),
- And/or clinical or ultrasound changes of the uterine cervix;
You likely can't join if
- Age \< 18 years;
- Premature rupture of membranes
- Patient in labor with imminent delivery.
- Total absence of social care
- Minor or protected adult (guardianship or curatorship)
- Persons who do not speak French and not accompanied by a French-speaking third party
See the full eligibility criteria
- Pregnant with live fetus(es)
- Emergency room visit between 22 and 34 days of pregnancy + 6 days
- For a suspicion of PTL defined by :
- Uterine contractions (UC) objectified during the consultation (questioning, clinical examination, external tocography),
- And/or clinical or ultrasound changes of the uterine cervix;
- OR for any other reason but with EC and/or clinical or ultrasound changes of the cervix on clinical examination
- Social security coverage or AME: patients receiving AME are at higher risk of PAD and preterm delivery.
- Signature of consent
- Age \< 18 years;
- Premature rupture of membranes
- Patient in labor with imminent delivery.
- Total absence of social care
- Minor or protected adult (guardianship or curatorship)
- Persons who do not speak French and not accompanied by a French-speaking third party
- Multiple pregnancy \>= 3
The study team makes the final eligibility decision.
Where it's taking place
- Colombes, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.