Preterm Birth, Preterm Birth Complication, Preterm Labor, Preterm Pregnancy, Preterm Premature Rupture of Membrane
Conditions
Keywords
Preterm, Biomarker, Pregnancy
Brief summary
This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.
Detailed description
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.
Interventions
OTHERSamples 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
OTHERSamples 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)
Sponsors
SPD Development Company Limited
Borne Charity
Chelsea and Westminster NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker | 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. |
| Correlation between the percentage of patients with reported demographic variables, lifestyle variables and clinical symptoms | 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. |
Countries
United Kingdom
Contacts
Primary ContactResearch Delivery Operations Manager
Backup ContactMark Johnson, MRCOG
Outcome results
None listed