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RECRUITING
NCT04374916
NA

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

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2020-08-11

Completion Date

2026-09

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

PARTOSURE®

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

Locations (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France