NCT04590677

Prediction of the Onset of Term and Preterm Labour

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Chelsea and Westminster NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Pregnancy
• Preterm Birth
• Preterm Birth Complication
• Preterm Premature Rupture of Membrane
• Preterm Labor

Interventions

Type	Name	Description
OTHER	Samples 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)
OTHER	Samples 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

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-09-01
• Completion: 2022-09-01
• First posted: 2020-10-19
• Last updated: 2021-08-09

Locations

1 site across 1 country: United Kingdom