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

Chelsea and Westminster NHS Foundation Trust

Status: Unknown

Conditions: Preterm Birth Complication; Preterm Premature Rupture of Membrane; Preterm Pregnancy; Preterm Labor; Preterm Birth

Treatments: Other: Samples required from group 2 (procedure within observational study); Other: Samples required from group 1 (procedure within observational study)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04590677

C&W19/037

Details and patient eligibility

About

This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

200 participants in 2 patient groups

Group 1

Description:

Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150.

Treatment:

Other: Samples required from group 1 (procedure within observational study)

Group 2

Description:

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.

Treatment:

Other: Samples required from group 2 (procedure within observational study)