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

ConditionsThreatened Preterm LaborPreterm Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Twin pregnancy

Sexual intercourse less than 24 hours from inclusion

Cervical cerclage

Abundant metrorrhagia

Trial design

Design model

Single group

Treatments tested in this trial

  • Premaquick®

    Device

    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®

    Device

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Partosure® test + Premaquick® testExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The 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.

Secondary outcomes

1

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)
2

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 )
3

Collection of the number of invalid results requiring restarting the Premaquick test.

Time frame
At the Inclusion visit Visit 0 (Day 0)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Strasbourg, France

Lead sponsor

Source ClinicalTrials.gov
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