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Interest of a Vaginal Swab in Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth

NCT03401255 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 341

Last updated 2022-09-08

No results posted yet for this study

Summary

Preterm labor is the first cause of hospitalization during the pregnancy, and at the origin of more than 60 000 births before 37 weeks of amenorrhea every year in France. It is however difficult to predict if a patient consulting in emergencies with symptoms of preterm labor, will give birth prematurely or not. Current diagnostic tools to identify patients with high risk of premature delivery in 7 days are insufficient because of their low positive predictive value. Yet the neonatal complications in case of premature delivery are important, with respiratory distress syndrome, hyaline membrane disease, necrotizing enterocolitis, intraventricular hemorrhage and post-natal death. Recent studies suggested that the detection of the placental alpha microglobulin 1 (PAMG-1) in the vaginal secretions, by Partosure® test at the women presenting symptoms of preterm labor with intact membranes would indicate that a premature spontaneous delivery could arise in 7 days with a good positive predictive value.The test is interesting all the more as the repetition of the prenatal cures of corticosteroids, aiming at the fetal lung maturation, is this day more recommended and as the beneficial effect takes place within 24 hours in 7 days following their administration. It seems thus essential to make studies to specify the interest of this test at the patients presenting a preterm labor. This study aims at estimating the diagnostic performance of the test of detection of PAMG-1 in the prediction of a delivery in 7 days, at the patients presenting symptoms of preterm labor.

Conditions

Interventions

OTHER

Partosure test

To perform the analysis, a sample of cervicovaginal secretions is collected using a vaginal swab provided in the PAMG-1 Detection Test Kit.After removing the swab from its packaging, hold the swab in the middle of the stem and carefully insert the end of the swab into the vagina over a length of 5-7cm (using a speculum). Is not necessary for sampling), when the patient is lying down.Remove the swab from the vagina after 30 seconds. Once the swab has been removed, immediately place the end in the solvent vial provided for this purpose, then rinse the swab by repeating several rotations for 30 seconds. The strip is removed as soon as two bands are clearly visible in the test area, or after 5 minutes.Two bands in the test area indicate a positive result, while a line in the test area indicates a negative result. It is not recommended to read or interpret results beyond 10 minutes of immersion.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Vincent Dochez, PH · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • France

Study Locations

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401255 on ClinicalTrials.gov