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.
Study Type
OBSERVATIONAL
Enrollment
200
* 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)
* Weekly maternal blood samples to be taken * Daily urine samples to be collected * One rectal swab at the initial visit only * Weekly vaginal swabs
Chelsea and Westminster Hospital
London, United Kingdom
RECRUITINGRelative 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.
Time frame: 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.
Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker
* 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.
Time frame: 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.
Time frame: 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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