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

NCT03401255 | Completed

• 1 other identifier: RC17_0247
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 2

Brief 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

Preterm Labor; Preterm Birth

Keywords

Placental alpha microglobulin-1; PAMG-1; preterm labor; preterm delivery; preterm birth; cervical length; transvaginal ultrasound; corticosteroid

Outcome Measures

Primary Outcomes (1)

• diagnostic performance of detection test of PAMG-1 for the prediction of imminent spontaneous preterm delivery within 7 days in patients presenting with symptoms of preterm labor

  The diagnostic performance of the test will be evaluated by estimating its specificity.

  time to delivery

Secondary Outcomes (13)

• sensitivity of detection test of PAMG-1

  time to delivery

• positive predictive of detection value test of PAMG-1

  time to delivery

• negative predictive of detection value test of PAMG-1

  time to delivery

• diagnostic performance of detection test of PAMG-1 in the prediction of imminent spontaneous preterm delivery within 48 hours in patients presenting with symptoms of preterm labor.

  time to delivery

• cervical length at inclusion

  within 48 hours after delivery

Interventions

Partosure test OTHER

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.

Eligibility Criteria

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

Study Population

patients presenting symptoms of preterm labor

You may qualify if:

• patients presenting for emergency obstetrical care with signs suggestive of preterm labor
• single pregnancy
• gestational age between 24 + 0 and 33SA + 6 weeks of gestation
• cervical length ≤ 25mm measurement on transvaginal ultrasound with or without uterine contraction
• informed consent
• consenting to be part of the trial

You may not qualify if:

• \< 18 years old or patient under guardianship / curators
• multiple pregnancy
• gestational term less than 24 SA or greater than or equal to 34 SA
• heavy vaginal bleeding- antecedent of conisation
• uterine malformation ( bicervical-bicorn uterus, unicervical bicorn uterus, unicorn uterus, septate uterus)
• Cervical dilatation \>3 cm.
• cervical length with transvaginal ultrasound \>25mm
• presence of a hydramnios with a superior amniotic fluid index 25
• premature rupture of manifest membranes (PROM)
• clinical or biological chorioamnionitis
• hooping cervical
• intercurrent obstetric pathology that can induce premature birth
• patient hospitalized for more than 24 hours in another hospital or service for preterm labor diagnosis

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

La Roche-sur-yon University Hospital

La Roche-sur-Yon, 85191, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

• Marie E, Ducarme G, Boivin M, Badon V, Pelerin H, Le Thuaut A, Lamoureux Z, Riche VP, Winer N, Thubert T, Dochez V. The value of a vaginal sample for detecting PAMG-1 (Partosure(R)) in women with a threatened preterm delivery (the MAPOSURE Study): protocol for a multicenter prospective study. BMC Pregnancy Childbirth. 2020 Aug 3;20(1):442. doi: 10.1186/s12884-020-03129-x.

  PMID: 32746802 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

To perform the analysis, a sample of cervicovaginal secretions is collected using a vaginal swab provided in the PAMG-1 Detection Test Kit.

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincent Dochez, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 17, 2018
• Study Start: February 28, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

FR (2)