Status:

COMPLETED

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

Lead Sponsor:

Nantes University Hospital

Conditions:

Preterm Labor

Preterm Birth

Eligibility:

FEMALE

18+ years

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 pr...

Detailed Description

Preterm labor is the first cause of hospitalization during the pregnancy and complicates of a premature delivery in about 30 % of the cases during single pregnancy. It is about a clinical situation ar...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • \< 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

Key Trial Info

Start Date :

February 28 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 28 2022

Estimated Enrollment :

341 Patients enrolled

Trial Details

Trial ID

NCT03401255

Start Date

February 28 2018

End Date

February 28 2022

Last Update

September 8 2022

Active Locations (2)

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Page 1 of 1 (2 locations)

1

La Roche-sur-yon University Hospital

La Roche-sur-Yon, France, 85191

2

Nantes University Hospital

Nantes, France, 44093