Prediction of the Onset of Term and Preterm Labour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-09-01

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Samples required from group 1 (procedure within observational study)

Intervention Type OTHER

* 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)

Group 2

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.

Samples required from group 2 (procedure within observational study)

Intervention Type OTHER

* Weekly maternal blood samples to be taken
* Daily urine samples to be collected
* One rectal swab at the initial visit only
* Weekly vaginal swabs

Interventions

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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)

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman
* 36 weeks gestational age

* 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

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

* 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

* 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes