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Prediction of the Onset of Term and Preterm Labour (PREDICT)

5. august 2021 oppdatert av: Chelsea and Westminster NHS Foundation Trust

Prediction of the Onset of Term and Preterm Labour (PREDICT)

This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Preterm birth is not a single entity but rather multifactorial The mechanisms underlying preterm birth are multifactorial and include stretch, oxidative stress, inflammation, infection and thrombosis. 85% of women have no identifiable risk factors for preterm birth and there is a requirement to develop a biomarker which can be used early in pregnancy to identify such women at risk. Equally important is to have a detection tool which will allow us to offer an individualised approach to preterm birth prevention and the women to benefit personalised surveillance and timely preventative measures such as cervical cerclage or progesterone.

The aim of this study is to collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour. We will use maternal blood, urine and vaginal secretion to look for biomarkers in these samples which can be use in the clinical setting to determine which women will go on to give birth preterm. This will allow clinicians to correctly identify these women and initiate treatment in the right woman to prevent preterm labour and birth. Equally important it will reduce unnecessary intervention and admission in those women who are not at risk.

Studietype

Observasjonsmessig

Registrering (Forventet)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Pregnant women

Beskrivelse

Group 1 inclusion criteria

  • Pregnant woman
  • 36 weeks gestational age

Group 1 exclusion criteria

  • Risk factors for preterm birth (previous preterm birth or second trimester loss, cervical suture, previous cervical treatment, previous full dilatation caesarean, transabdominal suture).
  • Planned Caesarean Section
  • Any high-risk pregnancy conditions such as PET (pre-eclamptic toxaemia), OC (Obstetric cholestasis), FGR (fetal growth restriction)
  • Unable to read written English
  • Unable to provide informed consent
  • Poor attendance with antenatal care
  • Uncertain gestational age

Exclusion criteria for subset within group 1 using heart rate monitor

  • Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS 10.0 (or later)
  • Skin condition where there is sensitivity to wearing a skin monitor
  • Known heart condition or use of a pacemaker
  • Taking any medications that may affect heart rate

Group 2 inclusion criteria

  • Pregnant woman
  • Presenting at or after 24 weeks gestational age and before 36 weeks / Symptoms of threatened preterm labour (abdominal pain) with fetal fibronectin level ≥ 50 ng/mL and without rupture of membranes
  • In-utero transfer with suspected threatened preterm labour with evidence of cervical shortening and dilatation with or without a fetal fibronectin
  • Rupture of membranes with or without contractions

Group 2 exclusion criteria

  • Any high-risk pregnancy conditions such as PET (pre-eclampsia), OC (Obstetric cholestasis), FGR (fetal growth restriction)
  • Unable to read written English
  • Unable to provide informed consent
  • Poor compliance with antenatal care
  • Uncertain gestational age

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Group 1
Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150.
Annen: Samples required from group 1 (procedure within observational study)
  • Weekly maternal blood samples to be taken
  • Daily urine samples to be collected
  • One rectal swab at the initial visit only
  • Weekly vaginal swabs
  • Daily Heart rate monitoring (only applicable to a subset of women in group 1)
Group 2
Pregnant women who have presented with signs and symptoms of threatened preterm labour (e.g. ruptured membranes, contractions, bleeding), at or after 24 weeks gestation, n=50.
Annen: Samples required from group 2 (procedure within observational study)
  • Weekly maternal blood samples to be taken
  • Daily urine samples to be collected
  • One rectal swab at the initial visit only
  • Weekly vaginal swabs

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour
Tidsramme: Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.
To use a combination of maternal blood, urine, rectal and vaginal swabs from pregnant to develop a biomarker to allow prediction of women at risk of preterm birth.
Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker
Tidsramme: Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.
  • To determine the temporal relationship between concentration of each biomarker e.g. hCG (IU/L), Progesterone (µg/ml) and onset of labour.
  • For biomarkers that demonstrate a clinically relevant relationship with onset of labour e.g. hCG (IU/L), Progesterone (µg/ml), the clinical utility of the biomarker will be determined.
Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.
Correlation between the percentage of patients with reported demographic variables, lifestyle variables and clinical symptoms
Tidsramme: Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.
To determine the correlation between the percentage of patients with reported demographic variables, lifestyle variables and clinical symptoms reported through questionnaires and a daily diary and the onset of preterm birth.
Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chelsea and Westminster NHS Foundation Trust

Samarbeidspartnere

SPD Development Company Limited
Borne Charity

Etterforskere

  • Hovedetterforsker: Natasha Singh, MRCOG, Chelsea and Westminster Hospital NHS Foundation Trust

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. oktober 2020

Primær fullføring (Forventet)

1. september 2021

Studiet fullført (Forventet)

1. september 2022

Datoer for studieregistrering

Først innsendt

21. september 2020

Først innsendt som oppfylte QC-kriteriene

9. oktober 2020

Først lagt ut (Faktiske)

19. oktober 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C&W19/037

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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