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Clinical Trials in France / NCT04374916
Recruiting Not applicable

Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor

NCT04374916 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Not applicable
Started
2020-08-11
Last updated
2026-08-21

Condition(s) studied

Threatened Preterm LaborPreterm Delivery

Investigational drug(s) / intervention(s)

Premaquick®PARTOSURE®

Premaquick®: Vaginal secretions are collected prior to any vaginal or endovaginal ultrasound examination to avoid false positives, with the nylon swab provided with the test (placed in the posterior fornix of the vagina for 10 seconds).Then the samples are tested with the Premaquick test. Results are obtained in 10 minutes.

PARTOSURE®: An immunochromatographic test wich determines the qualitative in vitro detection of placental alpha microglobulin-1 (PAMG-1) in cervico-vaginal secretions.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The primary outcome measure will be the occurrence of a premature delivery within 7 days after patient's inclusion. — The outcome measure is assessed at visit 2 (day 7), 7 days after the inclusion visit.

Trial sites (1)

FacilityCityRegionStatus
Hôpitaux Universitaires de Strasbourg Strasbourg France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04374916 on ClinicalTrials.gov ↗ ← All trials in France