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

August 5, 2021 updated by: Chelsea and Westminster NHS Foundation Trust

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150.
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)
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker
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 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.
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
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 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

SPD Development Company Limited
Borne Charity

Investigators

  • Principal Investigator: Natasha Singh, MRCOG, Chelsea And Westminster Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C&W19/037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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