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| Name | Class |
|---|---|
| SPD Development Company Limited | INDUSTRY |
| Borne Charity | UNKNOWN |
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This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samples required from group 1 (procedure within observational study) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker |
|
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Group 1 inclusion criteria
Group 1 exclusion criteria
Exclusion criteria for subset within group 1 using heart rate monitor
Group 2 inclusion criteria
Group 2 exclusion criteria
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Pregnant women
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Delivery Operations Manager | Contact | 020 3315 6825 | research.development@chewest.nhs.uk | |
| Mark Johnson, MRCOG | Contact | mark.johnson@chelwest.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Natasha Singh, MRCOG | Chelsea and Westminster NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital | Recruiting | London | SW10 9NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29880692 | Background | 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. | |
| 18640661 |
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Blood - Extraction for proteonomic and transcriptomic studies, single cell RNA extraction, DNA extraction and identification of biomarker.
Urine - Metabolomic studies, single cell RNA, proteonomic and transcriptomic studies and identification of biomarker.
Swabs - Cytokine analysis, microbiome Rectal swabs - cytokine and microbiome.
|
| Samples required from group 2 (procedure within observational study) | Other |
|
|
| 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 | 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. |
| 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. |
| 21167469 | Background | 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. |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| C563032 | Preterm Premature Rupture of the Membranes |
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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