NCT04374916

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Threatened Preterm Labor
• Preterm Delivery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-11
• Primary completion: 2022-08-25
• Completion: 2022-08-25
• First posted: 2020-05-05
• Last updated: 2021-10-07

Locations

1 site across 1 country: France