Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor (PREMAQUICK)
Primary Purpose
Threatened Preterm Labor, Preterm Delivery
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Premaquick®
PARTOSURE®
Sponsored by
About this trial
This is an interventional diagnostic trial for Threatened Preterm Labor focused on measuring Threatened preterm labor, Preterm Delivery, Preterm birth, IGFBP-1
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
Sites / Locations
- Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Partosure® test + Premaquick® test
Arm Description
All patients will have the same 2 tests.
Outcomes
Primary Outcome Measures
The primary outcome measure will be the occurrence of a premature delivery within 7 days after patient's inclusion.
Secondary Outcome Measures
Collection of the occurrence of a premature delivery within 7 days of inclusion, then calculation of specificity, positive and negative predictive values.
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.
Collection of the number of invalid results requiring restarting the Premaquick test.
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.
a new calculation algorithm to predict the risk of preterm delivery, based on the results observed in this study.
Full Information
NCT ID
NCT04374916
First Posted
April 30, 2020
Last Updated
October 6, 2021
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04374916
Brief Title
Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
Acronym
PREMAQUICK
Official Title
Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
August 25, 2022 (Anticipated)
Study Completion Date
August 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Threatened Preterm Labor, Preterm Delivery
Keywords
Threatened preterm labor, Preterm Delivery, Preterm birth, IGFBP-1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partosure® test + Premaquick® test
Arm Type
Experimental
Arm Description
All patients will have the same 2 tests.
Intervention Type
Device
Intervention Name(s)
Premaquick®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PARTOSURE®
Intervention Description
An immunochromatographic test wich determines the qualitative in vitro detection of placental alpha microglobulin-1 (PAMG-1) in cervico-vaginal secretions.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
Title
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 )
Title
Collection of the number of invalid results requiring restarting the Premaquick test.
Time Frame
At the Inclusion visit Visit 0 (Day 0)
Title
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)
Title
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine KOCH, PHD
Phone
+33 3 88 12 75 03
Email
antoine.koch@chru-strabourg.fr
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine KOCH, PHD
Phone
03 88 12 75 03
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
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