Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT03608995
Status:
UNKNOWN
Last Update Posted:
2018-08-29
First Post:
2018-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Tests in the Context of Threatened Preterm Labour
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Combined Detection of Interleukin-6 and Insulin-like Growth Factor Binding Protein-1 Total and Native (Premaquick) for the Prediction of Delivery in Women With Threatened Preterm Labor
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREMAQUICK
Brief Summary:
The primary purpose of the protocol is to compare the diagnostic accuracy in terms of positive and negative predictive values of Premaquick © (combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native) and Quikcheck fFN ™ (fibronectin detection) tests for prediction of spontaneous delivery within 7 days in women with threatened preterm labor. The study hypothesis is that combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native dice the admission will improve the prediction of delivery compared to the detection of fetal fibronectin alone in women with threatened preterm labor.
Detailed Description:
The threat of premature labour is the main cause of hospitalization during pregnancy (38% of hospitalizations). To date, the assessment of severity relies mainly on ultrasound measurement of the cervix. The length of the cervix is significantly correlated with the risk of spontaneous premature delivery. A threshold of 25mm is relevant to rule out a delivery within 7 days but the identification of new markers including biological would be interesting to guide the clinician in assessing the risk of preterm birth. Among the biomarkers measured in vaginal secretions, the detection of fetal fibronectin seems to be the most relevant because of a high negative predictive value (NPV) up to 100% to rule out a delivery within 7 days. However, the use of this test is discussed because of its low positive predictive value (PPV) to predict delivery within 7 days (from 11% to 48%). The use of Premaquick © test (Biosynex, Strasbourg, France), which allow the simultaneous quantification of IL-6, total IGFBP-1 and native IGFBP-1 could be more efficient compared to the detection of fibronectin by improving the VPP. The results already obtained on a cohort of 97 patients (Eleje et al., 2016) show a similar NPV and a higher PPV of the Premaquick© test compared to the Quikcheck fFN ™ test (PPV up to 95% when the 3 markers are positive). Investigator wish to conduct a comparative study between these two tests on a larger cohort of patients (n = 220). Results of the tests will be masked for the clinician and the patient in order to assess and compare their ability to predict delivery within 7 days without modify the current medical management.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-A00619-46 | OTHER | 2018-A00619-46 | View |