NCT04590677

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

September 21, 2020

Last Update Submit

August 5, 2021

Conditions

Preterm PregnancyPreterm BirthPreterm Birth ComplicationPreterm Premature Rupture of MembranePreterm Labor

Keywords

PretermBiomarkerPregnancy

Outcome Measures

Primary Outcomes (1)

  • Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour

    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 Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

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)

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)

Interventions

Samples required from group 1 (procedure within observational study)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 1
Samples required from group 2 (procedure within observational study)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

Group 2

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • Pregnant woman
  • weeks gestational age

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

RECRUITING

Related Publications (3)

  • Ngo TTM, Moufarrej MN, Rasmussen MH, Camunas-Soler J, Pan W, Okamoto J, Neff NF, Liu K, Wong RJ, Downes K, Tibshirani R, Shaw GM, Skotte L, Stevenson DK, Biggio JR, Elovitz MA, Melbye M, Quake SR. Noninvasive blood tests for fetal development predict gestational age and preterm delivery. Science. 2018 Jun 8;360(6393):1133-1136. doi: 10.1126/science.aar3819.

    PMID: 29880692BACKGROUND

  • Heng YJ, Di Quinzio MK, Permezel M, Rice GE, Georgiou HM. Interleukin-1 receptor antagonist in human cervicovaginal fluid in term pregnancy and labor. Am J Obstet Gynecol. 2008 Dec;199(6):656.e1-7. doi: 10.1016/j.ajog.2008.06.011. Epub 2008 Jul 21.

    PMID: 18640661BACKGROUND

  • Heng YJ, Di Quinzio MK, Permezel M, Rice GE, Georgiou HM. Cystatin A protease inhibitor and cysteine proteases in human cervicovaginal fluid in term pregnancy and labor. Am J Obstet Gynecol. 2011 Mar;204(3):254.e1-7. doi: 10.1016/j.ajog.2010.10.912. Epub 2010 Dec 16.

    PMID: 21167469BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood - Extraction for proteonomic and transcriptomic studies, single cell RNA extraction, DNA extraction and identification of biomarker. Urine - Metabolomic studies, single cell RNA, proteonomic and transcriptomic studies and identification of biomarker. Swabs - Cytokine analysis, microbiome Rectal swabs - cytokine and microbiome.

MeSH Terms

Conditions

Premature BirthPreterm Premature Rupture of the MembranesObstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Natasha Singh, MRCOG

    Chelsea and Westminster NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Delivery Operations Manager

CONTACT

020 3315 6825research.development@chewest.nhs.uk

Mark Johnson, MRCOG

CONTACT

mark.johnson@chelwest.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

October 19, 2020

Study Start

October 20, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2022

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)