Clinical trial NCT04374916: Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
Official title: Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Threatened Preterm Labor
Preterm Delivery
Keywords: Threatened preterm labor
Preterm Delivery
Preterm birth
IGFBP-1
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 criteria: 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 outcomes:
measure: The primary outcome measure will be the occurrence of a premature delivery within 7 days after patient's inclusion.
timeFrame: The outcome measure is assessed at visit 2 (day 7), 7 days after the inclusion visit.
Secondary outcomes:
measure: Collection of the occurrence of a premature delivery within 7 days of inclusion, then calculation of specificity, positive and negative predictive values.
timeFrame: At visit 2, Day 7 (7 days after inclusion visit V0)
measure: 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.
timeFrame: At visit 1, Day 2 (2 days after inclusion visit ) and D14 (14 days after inclusion visit )
measure: Collection of the number of invalid results requiring restarting the Premaquick test.
timeFrame: At the Inclusion visit Visit 0 (Day 0)
measure: 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.
timeFrame: At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
measure: a new calculation algorithm to predict the risk of preterm delivery, based on the results observed in this study.
timeFrame: At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: