Diagnostic Tests in the Context of Threatened Preterm Labour (PREMAQUICK)

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Predictive Value of Tests

Biomarkers

Preterm Delivery

Immunochromatographic Assay

Preterm Labor

Treatments

Diagnostic Test: Quikcheck fFN ™

Diagnostic Test: Premaquick (Diagnostic test)

Study type

Interventional

Funder types

Other

Identifiers

NCT03608995

CHU-394

2018-A00619-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Major pregnant women admitted to Clermont-Ferrand CHU maternity for threatened preterm delivery with intact membranes between 24 and 34 (+6 days) week of amenorrhea, with length of cervix < 30mm (ultrasound measurement).
Ability to give informed consent.
French social security scheme.

Exclusion criteria