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Identification of Spontaneous Delivery Markers (TrophY2)

15. juni 2018 opdateret af: Assistance Publique - Hôpitaux de Paris

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

238

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Paris, Frankrig, 75014
        • Maternité Port Royal-Cochin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
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
Eksperimentel: Preterm Labor
Pregnant women admitted for preterm labor
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
Eksperimentel: 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
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Delivery
Tidsramme: until Day 14
Assessed among patients in preterm labor between 24 - 32 GA
until Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Delivery before 34 GA
Tidsramme: until Day 14
Assessed among patients in preterm labor between 24 - 32 GA
until Day 14
composite Prenatal maternal care
Tidsramme: until Delivery

Assessed by :

  • number of hospitalization,
  • total duration of hospitalization for preterm labor,
  • use of tocolytic treatment, administration of prenatal corticotherapy,
  • time between the last injection of corticosteroids and birth
until Delivery
composite Neonatal outcome
Tidsramme: At Birth

Assessed by :

  • birth weight,
  • Apgar score at 5 minutes,
  • arterial cord pH,
  • transfer to neonatology unit or neonatal intensive care,
  • death,
  • In case of transfer neonatal unit or neonatal intensive care : duration of hospitalization, use of respiratory assistance
At Birth
composite Obstetric outcome
Tidsramme: At Delivery

Assessed by :

  • pregnancy term,
  • way to start labor (spontaneous, induction, caesarean before labor)
  • duration of labor,
  • maternal fever,
  • antibiotics during labor,
  • mode of delivery,
  • indications of cesarean
At Delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Celine MEHATS, PhD, INSERM U1016 - Cochin Hospital Public Hospitals of Paris

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. december 2014

Primær færdiggørelse (Faktiske)

14. november 2017

Studieafslutning (Faktiske)

16. april 2018

Datoer for studieregistrering

Først indsendt

7. august 2014

Først indsendt, der opfyldte QC-kriterier

25. august 2014

Først opslået (Skøn)

26. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cervicovaginal swab

3
Abonner