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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
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.
An immunochromatographic test wich determines the qualitative in vitro detection of placental alpha microglobulin-1 (PAMG-1) in cervico-vaginal secretions.
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
RECRUITINGThe primary outcome measure will be the occurrence of a premature delivery within 7 days after patient's inclusion.
Time frame: The outcome measure is assessed at visit 2 (day 7), 7 days after the inclusion visit.
Collection of the occurrence of a premature delivery within 7 days of inclusion, then calculation of specificity, positive and negative predictive values.
Time frame: At visit 2, Day 7 (7 days after inclusion visit V0)
Collection of the occurrence of a premature delivery on Day 2 and Day 14 following the inclusion, then calculation of the sensitivities, specificities, positive and negative predictive values.
Time frame: At visit 1, Day 2 (2 days after inclusion visit ) and D14 (14 days after inclusion visit )
Collection of the number of invalid results requiring restarting the Premaquick test.
Time frame: At the Inclusion visit Visit 0 (Day 0)
Collection of premature deliveries at different times (2, 7 and 14 days after inclusion visit), then comparison of the sensitivities and specificities of the two tests at different times.
Time frame: At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
a new calculation algorithm to predict the risk of preterm delivery, based on the results observed in this study.
Time frame: At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
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