Prediction of the Onset of Term and Preterm Labour

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prediction of the Onset of Term and Preterm Labour (PREDICT)

Conditions
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Preterm Pregnancy, Preterm Birth, Preterm Birth Complication, Preterm Premature Rupture of Membrane, Preterm Labor

Intervention / Treatment
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* Other: Samples required from group 1 (procedure within observational study)
* Other: Samples required from group 2 (procedure within observational study)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150. | Other: Samples required from group 1 (procedure within observational study)<br>* 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)<br>|
| Group 2<br>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. | Other: Samples required from group 2 (procedure within observational study)<br>* Weekly maternal blood samples to be taken Daily urine samples to be collected One rectal swab at the initial visit only Weekly vaginal swabs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm, Biomarker, Pregnancy