Prediction of the Onset of Term and Preterm Labour (PREDICT)
5 augusti 2021 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
200
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Research Delivery Operations Manager
- Telefonnummer: 020 3315 6825
- E-post: research.development@chewest.nhs.uk
Studera Kontakt Backup
- Namn: Mark Johnson, MRCOG
- E-post: mark.johnson@chelwest.nhs.uk
Studieorter
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London, Storbritannien, SW10 9NH
- Rekrytering
- Chelsea And Westminster Hospital
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Kontakt:
- Research Delivery Operations Manager
- E-post: research.development@chelwest.nhs.uk
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Huvudutredare:
- Natasha Singh, MRCOG
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Pregnant women
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Group 1
Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour
Tidsram: 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.
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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.
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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.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker
Tidsram: 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.
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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.
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Correlation between the percentage of patients with reported demographic variables, lifestyle variables and clinical symptoms
Tidsram: 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.
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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.
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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.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Natasha Singh, MRCOG, Chelsea And Westminster Hospital NHS Foundation Trust
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Ngo TTM, Moufarrej MN, Rasmussen MH, Camunas-Soler J, Pan W, Okamoto J, Neff NF, Liu K, Wong RJ, Downes K, Tibshirani R, Shaw GM, Skotte L, Stevenson DK, Biggio JR, Elovitz MA, Melbye M, Quake SR. Noninvasive blood tests for fetal development predict gestational age and preterm delivery. Science. 2018 Jun 8;360(6393):1133-1136. doi: 10.1126/science.aar3819.
- Heng YJ, Di Quinzio MK, Permezel M, Rice GE, Georgiou HM. Interleukin-1 receptor antagonist in human cervicovaginal fluid in term pregnancy and labor. Am J Obstet Gynecol. 2008 Dec;199(6):656.e1-7. doi: 10.1016/j.ajog.2008.06.011. Epub 2008 Jul 21.
- Heng YJ, Di Quinzio MK, Permezel M, Rice GE, Georgiou HM. Cystatin A protease inhibitor and cysteine proteases in human cervicovaginal fluid in term pregnancy and labor. Am J Obstet Gynecol. 2011 Mar;204(3):254.e1-7. doi: 10.1016/j.ajog.2010.10.912. Epub 2010 Dec 16.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 oktober 2020
Primärt slutförande (Förväntat)
1 september 2021
Avslutad studie (Förväntat)
1 september 2022
Studieregistreringsdatum
Först inskickad
21 september 2020
Först inskickad som uppfyllde QC-kriterierna
9 oktober 2020
Första postat (Faktisk)
19 oktober 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 augusti 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 augusti 2021
Senast verifierad
1 augusti 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C&W19/037
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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