NCT04374916 Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
| NCT ID | NCT04374916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Threatened Preterm Labor |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-08-11 |
| Primary Completion | 2025-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2020-08-11 with a primary completion date of 2025-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Threatened preterm labor (TPL) is defined by cervical changes and regular and painful uterine contractions occurring between 24 and 36 + 6 weeks of gestation that may or may not lead to premature labor and delivery. There is no reliable way to predict preterm delivery. The study's hypothesis is that the Premaquick® test can improve the prediction of preterm delivery. The investigators also want to compare this test with the Partosure® (Placental alpha microglobulin-1) test.
Eligibility Criteria
Inclusion Criteria: * Patient aged \> 18 years (with no upper age limit) * Patient affiliated to a social security health regime * Between 24 and 33 + 6 weeks of gestation (amenorrhea) * Singleton pregnancy * Patient with a TPL: Uterine contractions during the last 24 hours felt by the patient, painful or not, and cervix less than or equal to 25 mm on endovaginal ultrasound * Having signed an informed consent form Exclusion Criteria: * Twin pregnancy * Sexual intercourse less than 24 hours from inclusion * Cervical cerclage * Abundant metrorrhagia * Premature rupture of membranes * Pre-eclampsia * Congenital malformation * Presence of a placenta previa * Pelvic examination in the previous 24 hours (compared to inclusion) * Patient under guardianship, curatorship or safeguard of justice * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care under duress
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04374916 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Threatened Preterm Labor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04374916 currently recruiting?
Yes, NCT04374916 is actively recruiting participants. Contact the research team at antoine.koch@chru-strabourg.fr for enrollment information.
Where is the NCT04374916 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT04374916 clinical trial?
NCT04374916 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 200 participants.