NCT04374916

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 11, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

April 30, 2020

Last Update Submit

October 6, 2021

Conditions

Threatened Preterm LaborPreterm Delivery

Keywords

Threatened preterm laborPreterm DeliveryPreterm birthIGFBP-1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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)

Study Arms (1)

Partosure® test + Premaquick® test

EXPERIMENTAL

All patients will have the same 2 tests.

Device: Premaquick®Device: PARTOSURE®

Interventions

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® test + Premaquick® test
PARTOSURE®DEVICE

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

Partosure® test + Premaquick® test

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Twin pregnancy
  • Cervical cerclage
  • Abundant metrorrhagia
  • Premature rupture of membranes
  • Pre-eclampsia
  • Congenital malformation
  • Presence of a placenta previa
  • Patient under guardianship, curatorship or safeguard of justice
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons under psychiatric care under duress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Antoine KOCH, PHD

CONTACT

+33 3 88 12 75 03antoine.koch@chru-strabourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 5, 2020

Study Start

August 11, 2020

Primary Completion

August 25, 2022

Study Completion

August 25, 2022

Last Updated

October 7, 2021

Record last verified: 2021-09

Locations

FR(1)