Diagnostic Tests in the Context of Threatened Preterm Labour

Not Applicable

• Conditions: Predictive Value of Tests; Biomarkers; Preterm Labor; Immunochromatographic Assay; Preterm Delivery
• Interventions: Diagnostic Test: Quikcheck fFN ™; Diagnostic Test: Premaquick (Diagnostic test)

• Registration Number: NCT03608995
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-07-24
• Status Verified: 2018-08
• Study First Posted: 2018-08-01
• Study Start: 2018-08-21
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29
• Primary Completion: 2019-12-30
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

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.

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Exclusion Criteria

• • Dilation of the cervix ≥ 4 cm
• Triple pregnancy or more
• Fetal membranes rupture
• Known uterine malformation
• Hydramnios
• Fetal malformation
• Placenta previa
• Abundant metrorrhagia
• Patient who had already participated in the study during the same pregnancy
• Patient under guardianship or curatorship

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quikcheck	Quikcheck fFN ™	-
Premaquick©	Premaquick (Diagnostic test)	-

Primary Outcome Measures

Name	Time	Method
Diagnostic value of Premaquick and Quikcheck fFN ™ tests to predict delivery within 7 days (yes / no).	Results of the tests are given by the biochemistry department after a minimum of 15 days after the tests have been performed. The date of delivery is obtained by analyzing the patient file.	The results (positive / negative) of the Premaquick and Quikcheck fFN ™ tests and the delay between the test and delivery time (in days) will allow to determine the PPV and NPV of the tests to predict delivery within 7 days.

Secondary Outcome Measures

Name	Time	Method
Number of positive markers of the Premaquick test	up to 17 weeks	Number of positive / negative markers (0, 1, 2 or 3)
Number of negative markers of the Premaquick test	up to 17 weeks	Number of positive / negative markers (0, 1, 2 or 3)

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France