Diagnostic Tests in the Context of Threatened Preterm Labour

NCT03608995 | Completed

• 2 other identifiers: CHU-3942018-A00619-46
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor; Immunochromatographic Assay; Predictive Value of Tests; Preterm Delivery; Biomarkers

Keywords

preterm labor; biomarkers; Preterm delivery threat

Outcome Measures

Primary Outcomes (1)

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

  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.

  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.

Secondary Outcomes (2)

• Number of positive markers of the Premaquick test

  up to 17 weeks

• Number of negative markers of the Premaquick test

  up to 17 weeks

Study Arms (2)

Premaquick©

EXPERIMENTAL

Diagnostic Test: Premaquick (Diagnostic test)

Quikcheck

OTHER

Diagnostic Test: Quikcheck fFN ™

Interventions

Quikcheck fFN ™ DIAGNOSTIC_TEST

\- The Hologic QuikCheck fFN test is intended to be used for the qualitative detection of fetal fibronectin in cervicovaginal secretions. The presence of fetal fibronectin in cervicovaginal secretions between 22 weeks, 0 days and 34 weeks, 6 days of gestation is associated with elevated risk of preterm delivery. Quick Check fFN test® is a 10 min, one-step, visual test consists of a sterile polyester-tipped applicator, fetal fibronectin test strip, and sample extraction buffer. The QuikCheck fFN is a solid-phase immunogold assay which aim to detect fetal fibronectin. A positive specimen will result in two visible lines and a negative specimen will result in one visible line (control).

Quikcheck

Premaquick (Diagnostic test) DIAGNOSTIC_TEST

PREMAQUICK® is a rapid multiparametric test which aim to detect the presence of IGFBP-1 (Insulin-like Growth Factor-Binding Protein 1), fragmented IGFBP-1 and IL-6 (Interleukin 6) in vaginal secretions. By combining biomarkers of myometrial activation, cervical maturity and inflammation / infection, PREMAQUICK® integrates the main pathogenic mechanisms responsible for premature delivery, which makes it possible to predict or, on the contrary, rule out the risk of childbirth within 7 to 14 days. This test is intended for in vitro diagnostic use. Vaginal secretions are collected under speculum with a swab (10 seconds of impregnation of the swab). The swab is immersed in a tube containing an extraction buffer for 10 seconds. The tube is mixed and then 3 drops are deposited in each wells of the test device for 10 minutes. Visual reading should be done between 10 and 15 minutes.

Premaquick©

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Mr. Thierry PAPER - Biosynex Company: collaborator
• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (5)

• Compan C, Rossi A, Piquier-Perret G, Delabaere A, Vendittelli F, Lemery D, Gallot D. [Prediction of spontaneous preterm birth in symptomatic patients: A review]. J Gynecol Obstet Biol Reprod (Paris). 2015 Oct;44(8):740-51. doi: 10.1016/j.jgyn.2015.06.008. Epub 2015 Jun 29. French.

  PMID: 26139036 BACKGROUND

• Deplagne C, Maurice-Tison S, Coatleven F, Vandenbossche F, Horovitz J. [Sequential use of cervical length measurement before fetal fibronectin detection to predict spontaneous preterm delivery in women with preterm labor]. J Gynecol Obstet Biol Reprod (Paris). 2010 Nov;39(7):575-83. doi: 10.1016/j.jgyn.2010.08.001. Epub 2010 Sep 29. French.

  PMID: 20884131 BACKGROUND

• Eleje GU, Ezugwu EC, Eke AC, Eleje LI, Ikechebelu JI, Ezebialu IU, Obiora CC, Nwosu BO, Ezeama CO, Udigwe GO, Okafor CI, Ezugwu FO. Accuracy of a combined insulin-like growth factor-binding protein-1/interleukin-6 test (Premaquick) in predicting delivery in women with threatened preterm labor. J Perinat Med. 2017 Nov 27;45(8):915-924. doi: 10.1515/jpm-2016-0339.

  PMID: 28236632 BACKGROUND

• Sentilhes L, Senat MV, Ancel PY, Azria E, Benoist G, Blanc J, Brabant G, Bretelle F, Brun S, Doret M, Ducroux-Schouwey C, Evrard A, Kayem G, Maisonneuve E, Marcellin L, Marret S, Mottet N, Paysant S, Riethmuller D, Rozenberg P, Schmitz T, Torchin H, Langer B. [Prevention of spontaneous preterm birth (excluding preterm premature rupture of membranes): Guidelines for clinical practice - Text of the Guidelines (short text)]. J Gynecol Obstet Biol Reprod (Paris). 2016 Dec;45(10):1446-1456. doi: 10.1016/j.jgyn.2016.09.011. Epub 2016 Nov 9. French.

  PMID: 27836377 BACKGROUND

• Pambet M, Sirodot F, Pereira B, Cahierc R, Delabaere A, Comptour A, Rouzaire M, Sapin V, Gallot D. Benefits of Premaquick(R) Combined Detection of IL-6/Total IGFBP-1/Native IGFBP-1 to Predict Preterm Delivery. J Clin Med. 2023 Sep 1;12(17):5707. doi: 10.3390/jcm12175707.

  PMID: 37685773 RESULT

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Denis GALLOT

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: August 1, 2018
• Study Start: August 21, 2018
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)