Prediction of the Onset of Term and Preterm Labour (PREDICT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Pregnancy
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour
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.
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 Outcomes
- 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.)
- 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.)