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

Not Applicable

• Conditions: Preterm Delivery; Threatened Preterm Labor
• Interventions: Device: Premaquick®; Device: PARTOSURE®

• Registration Number: NCT04374916
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Study Start: 2020-08-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partosure® test + Premaquick® test	Premaquick®	All patients will have the same 2 tests.
Partosure® test + Premaquick® test	PARTOSURE®	All patients will have the same 2 tests.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the occurrence of a premature delivery within 7 days after patient's inclusion.	The outcome measure is assessed at visit 2 (day 7), 7 days after the inclusion visit.

Secondary Outcome Measures

Name	Time	Method
Collection of the number of invalid results requiring restarting the Premaquick test.	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.	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.	At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
Collection of the occurrence of a premature delivery within 7 days of inclusion, then calculation of specificity, positive and negative predictive values.	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.	At visit 1, Day 2 (2 days after inclusion visit ) and D14 (14 days after inclusion visit )

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France