- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02225717
Identification of Spontaneous Delivery Markers (TrophY2)
Markers of Fetal Membranes Remodelling in Cervicovaginal Fluid and Delivery
The investigators project aims to identify, in pregnant women, discriminating molecules to allow an early detection of women who will spontaneously deliver prematurely, suitable in routine clinical practice.
Human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and fetal membranes (the water bag) remodelling. Precocious remodelling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not.
In this regard, remodelled fetal membranes overlying the cervix may discharge signals that could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Prematurity is a major Public Health concern in developed countries, since it is the first cause of perinatal morbi-mortality and of cerebral palsy in early childhood. Premature birth rate has risen by 36 percent over the last 25 years to reach 7.2% in 2010 in France. Antenatal corticosteroids administration before 34 weeks and in utero transfer in high-qualified maternity wards are ones of the rare antenatal therapies recommended to improve neonatal complications of preterm delivery. Early identification of women with high risk of preterm birth should be helpful to implement those prophylactic measures. Moreover discriminating true preterm labor (PTL) vs. symptoms of PTL in women, who will finally deliver at term, would reduce unnecessary hospitalizations and prescriptions.
During human gestation, fetal membranes (the "water bag") encompass the amnion, facing the amniotic cavity, and the chorion, lining the maternal decidua and comprising trophoblast cells. Membranes usually remain intact until their spontaneous rupture, close to the first stage of labor at term. Often seen as a simple inert shell, with a role of "airbag" for the developing fetus, the membranes provide yet a large surface of interaction between maternal and fetal tissues and function as a transient endocrine organ with immune properties.
Specific remodelling of the membranes is observed at term prior to delivery. During this remodelling, drastic changes in extracellular matrix occur, with the secretion of specific molecules. The investigators hypothesize that premature fetal membranes remodelling occurs weeks prior to actual birth and may be able to be detected in women at risk for preterm birth, i.e. presenting signs of PTL. This study investigates if the detection of fetal membranes remodelling in cervico-vaginal fluids can accurately identify those women at greatest risk for preterm birth. A prospective cohort of pregnant women will before 32 weeks of gestation with symptoms of preterm labor be enrolled. As negative controls, healthy pregnant women at 12-15 or 35-36 weeks of gestation or non-pregnant women will be recruited. As positive controls, healthy pregnant woman at term (over 38 weeks of gestation) will be enrolled. The main outcome assessed is preterm delivery.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Paris, Francia, 75014
- Maternité Port Royal-Cochin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Singleton pregnancy, monitored in Port Royal or secondarily transferred, between 24 and 32 GA. Hospitalization for preterm labor (cervix < 25 mm at transvaginal cervical ultrasound) or -Singleton pregnancy, monitered in Port Royal between 15-16 weeks of gestation, without complication.
or - Singleton pregnancy, monitered in Port Royal between 35-36 weeks of gestation, without complication.
or - Healthy woman, no pregnancy.
Exclusion Criteria:
- Minor
- Not affiliated to health insurance
- Persons under guardianship or judicial protection
- Infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
- Diabetes or chronic inflammatory disease
- Carrier of B streptococcus
- Cervical strapping
- Fetus with chromosomal abnormalities
- Infections
- Premature rupture of membrane
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Non pregnant women
Healthy pregnancy : women 15-16 weeks of gestation, at 35-36 weeks of gestation, and >37 weeks of gestation and planed cesarean prior labor
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Sample of cervicovaginal secretions made by the surgical team using a sterile swab introduced directly into the posterior fornix of vagina for one minute during the insertion of the urinary catheter
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Sperimentale: Preterm Labor
Pregnant women admitted for preterm labor
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Sample of cervicovaginal secretions made by the surgical team using a sterile swab introduced directly into the posterior fornix of vagina for one minute during the insertion of the urinary catheter
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Sperimentale: Healthy pregnancy
Healthy pregnancy : women 15-16 weeks of gestation, at 35-36 weeks of gestation, and >37 weeks of gestation and planed cesarean prior labor
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Sample of cervicovaginal secretions made by the surgical team using a sterile swab introduced directly into the posterior fornix of vagina for one minute during the insertion of the urinary catheter
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Delivery
Lasso di tempo: until Day 14
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Assessed among patients in preterm labor between 24 - 32 GA
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until Day 14
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Delivery before 34 GA
Lasso di tempo: until Day 14
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Assessed among patients in preterm labor between 24 - 32 GA
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until Day 14
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composite Prenatal maternal care
Lasso di tempo: until Delivery
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Assessed by :
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until Delivery
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composite Neonatal outcome
Lasso di tempo: At Birth
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Assessed by :
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At Birth
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composite Obstetric outcome
Lasso di tempo: At Delivery
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Assessed by :
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At Delivery
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Celine MEHATS, PhD, INSERM U1016 - Cochin Hospital Public Hospitals of Paris
Pubblicazioni e link utili
Pubblicazioni generali
- Larroque B, Ancel PY, Marret S, Marchand L, Andre M, Arnaud C, Pierrat V, Roze JC, Messer J, Thiriez G, Burguet A, Picaud JC, Breart G, Kaminski M; EPIPAGE Study group. Neurodevelopmental disabilities and special care of 5-year-old children born before 33 weeks of gestation (the EPIPAGE study): a longitudinal cohort study. Lancet. 2008 Mar 8;371(9615):813-20. doi: 10.1016/S0140-6736(08)60380-3.
- McLaren J, Malak TM, Bell SC. Structural characteristics of term human fetal membranes prior to labour: identification of an area of altered morphology overlying the cervix. Hum Reprod. 1999 Jan;14(1):237-41. doi: 10.1093/humrep/14.1.237.
- Malak TM, Bell SC. Structural characteristics of term human fetal membranes: a novel zone of extreme morphological alteration within the rupture site. Br J Obstet Gynaecol. 1994 May;101(5):375-86. doi: 10.1111/j.1471-0528.1994.tb11908.x.
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P140502
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Prove cliniche su Cervicovaginal swab
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University of California, San FranciscoCentral California Faculty Medical GroupCompletatoClamidia Trachomatis | Neisseria gonorrhoeaeStati Uniti