Prediction of the Onset of Term and Preterm Labour (PREDICT)
Prediction of the Onset of Term and Preterm Labour (PREDICT)
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Research Delivery Operations Manager
- 电话号码:020 3315 6825
- 邮箱:research.development@chewest.nhs.uk
研究联系人备份
- 姓名:Mark Johnson, MRCOG
- 邮箱:mark.johnson@chelwest.nhs.uk
学习地点
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London、英国、SW10 9NH
- 招聘中
- Chelsea And Westminster Hospital
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接触:
- Research Delivery Operations Manager
- 邮箱:research.development@chelwest.nhs.uk
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首席研究员:
- Natasha Singh, MRCOG
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Natasha Singh, MRCOG、Chelsea And Westminster Hospital NHS Foundation Trust
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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早产的临床试验
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University Hospitals Cleveland Medical CenterThe Cleveland Clinic; MetroHealth Medical Center招聘中早产 | 怀孕早产 | 舞会(怀孕) | 怀孕舞会 | PROM,早产(怀孕) | Premat Rupture Membranes Preterm 未指定破裂/分娩之间的时间长度美国