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MAPOSUREProspective Multicentric Study Estimating the Interest of a Vaginal Swab in Detection of Placental Alpha-Microglobulin-1 (Partosure®) in the Prediction of Preterm Birth

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Quiénes están siendo reclutados

Enfermedades Urogenitales+2

+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo

+ Trabajo de parto prematuro

A partir de 18 años
+19 Criterios de eligibilidad
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Cómo está diseñado el estudio

Solo Casos

Examinando las características de las personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.
Observacional
Inicio del estudio: febrero de 2018
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Resumen

Patrocinador PrincipalNantes University Hospital
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 28 de febrero de 2018

Fecha en la que se inscribió al primer participante.

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 arising between 22 and 36 amenorrhea weeks (SA) + 6 days, which are observed the cervical modifications and the uterine contractions confirmed by an ultrasound measure with cervical length ≤25mm.The main complication of the threat premature delivery (MAP) is the premature birth, which is an essential factor of perinatal morbidity and is the second cause of death before the age of 5 years. The measure of cervical length with ultrasound and the detection of the fetal fibronectin were estimated to identify the patients with risk of spontaneous premature delivery, however their capacity to discriminate these patients is insufficient (predictive value is positive of 20 %). It thus seems necessary to find a diagnostic alternative more relevant.The prenatal corticosteroid therapy is recommended for all the patients at risk of premature delivery in 7 days between 24 and 34 SA. Indeed the maximal profit of corticoids arises when the delivery occurs between 12 hours and 7 days following their administration, with a significant reduction in neonatal period the hyaline membrane diseases (50 %), intraventricular hemorrhage, necrotizing enterocolitis and deaths (40 %). Thus corticosteroids establishes the most important treatment in the prematurity.However, the beneficial effect of the corticosteroid therapy decreases if the birth arises beyond 7 days after the administration. So the efficiency of a complete cure of corticoids in the prevention of the neonatal respiratory morbidity is in connection with deadline between the administration and the delivery. The challenge consists in administering the cure of corticoids in 7 days preceding the birth to benefit from the maximal neonatal profit. Besides, the repetition of the cures of corticoids could be responsible for noxious effects on the future of the future adult by distorting the growth of the child and its cognitive future, by increasing the risk of obesity or insulin resistance, as well as the cardiovascular risk in the adulthood.The capacity to discriminate between the patients who are going to give birth prematurely in 7 days so answers a double objective: allow the implementation of an effective and beneficial preventive treatment for the newborn child and avoid treatments and inconvenient hospitalizations, generators of unwanted effects and useless spending.A recent study estimates the interest of an interesting molecule, the placental alpha microglobulin 1 (PAMG-1), in this diagnostic approach. She concludes that the detection of PAMG-1 by a vaginal taking is the best test to predict spontaneous delivery in 7 days compared with the measure of the cervical length by transvaginal ultrasound and the test of fetal fibronectin. If the performance of the test is validated by the study, the coverage of the patients would be optimized with less frequent and less long hospitalizations, as well as a decrease of treatments pointlessly prescribed at the patients not giving birth finally prematurely (tocolytics, corticoids). For those giving birth prematurely, corticoids could be administered for an optimal deadline to obtain the maximal profit for the newborn child.

Título OficialProspective Multicentric Study Estimating the Interest of a Vaginal Swab in Detection of Placental Alpha-Microglobulin-1 (Partosure®) in the Prediction of Preterm Birth
NCT03401255
Patrocinador PrincipalNantes University Hospital
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 341 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Solo Casos

Estos estudios se centran únicamente en personas con una enfermedad específica. Se analizan patrones, frecuentemente genéticos o ambientales, para identificar posibles factores relacionados con la condición.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades UrogenitalesEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoTrabajo de parto prematuroComplicaciones del trabajo de partoComplicaciones del embarazo

Criterios

6 criterios de inclusión requeridos para participar
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

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13 criterios de exclusión impiden participar
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

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 2 ubicaciones

Suspendido

La Roche-sur-yon University Hospital

La Roche-sur-Yon, FranceAbrir La Roche-sur-yon University Hospital en Google Maps
Suspendido

Nantes University Hospital

Nantes, France
Completado2 Centros de Estudio