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Clinical Trials/NCT03608995
NCT03608995UnknownNot Applicable

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

University Hospital, Clermont-Ferrand2 sites in 1 country220 target enrollmentStarted: August 21, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
220
Locations
2
Primary Endpoint
Diagnostic value of Premaquick and Quikcheck fFN ™ tests to predict delivery within 7 days (yes / no).

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

  • - 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

Arms & Interventions

Quikcheck

Other

Intervention: Quikcheck fFN ™ (Diagnostic Test)

Premaquick©

Experimental

Intervention: Premaquick (Diagnostic test) (Diagnostic Test)

Outcomes

Primary Outcomes

Diagnostic value of Premaquick and Quikcheck fFN ™ tests to predict delivery within 7 days (yes / no).

Time Frame: 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 Outcomes

  • Number of positive markers of the Premaquick test(up to 17 weeks)
  • Number of negative markers of the Premaquick test(up to 17 weeks)

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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