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NCT Number: NCT04374916

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

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.

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Key information

Conditions

Threatened Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Delivery Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Antoine KOCH, PHD

CONTACT

03 88 12 75 03

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine KOCH, PHD

CONTACT

[email protected]

+33 3 88 12 75 03

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: PREMAQUICK

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
May 5, 2020
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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