Prediction of the Onset of Term and Preterm Labour

• Conditions: Preterm Birth; Preterm Birth Complication; Preterm Premature Rupture of Membrane; Preterm Pregnancy; Preterm Labor
• Interventions: Other: Samples required from group 2 (procedure within observational study); Other: Samples required from group 1 (procedure within observational study)

• Registration Number: NCT04590677
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Study Start: 2020-10-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09
• Primary Completion: 2021-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Samples required from group 2 (procedure within observational study)	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.
Group 1	Samples required from group 1 (procedure within observational study)	Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom