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

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 Overview

• Status: Recruiting
• Conditions: Preterm Delivery; Threatened Preterm Labor
• Intervention / Treatment: Device: Premaquick®; Device: PARTOSURE®

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine KOCH, PHD; Phone Number: +33 3 88 12 75 03; Email: antoine.koch@chru-strabourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Antoine KOCH, PHD; Phone Number: 03 88 12 75 03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Partosure® test + Premaquick® test; All patients will have the same 2 tests.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 )
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)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Anticipated): August 25, 2022
• Study Completion (Anticipated): August 25, 2022

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Preterm birth; Preterm Delivery; Threatened preterm labor; IGFBP-1
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 7353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No