Preterm PregnancyPREDICTNCT04590677
Prediction of the Onset of Term and Preterm Labour
An observational study of Preterm Pregnancy and Preterm Birth, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Pregnancy, Preterm Birth, Preterm Birth Complication
- What is being tested?
- Samples required from group 1 (procedure within observational study) and Samples required from group 2 (procedure within observational study)
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women
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 locations and contacts
1 site in 1 country.
Mark Johnson, MRCOG contact
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster Hospital
London, SW10 9NH
Research Delivery Operations Manager, research.development@chelwest.nhs.uk
Natasha Singh, MRCOG
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Pregnancy, Preterm Birth, Preterm Birth Complication, Preterm Premature Rupture of Membrane, Preterm Labor
- Being tested
- Samples required from group 1 (procedure within observational study), Samples required from group 2 (procedure within observational study)
- Keywords
- Preterm, Biomarker, Pregnancy
- Medical subject headings
- Premature Birth, Preterm Premature Rupture of the Membranes, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pregnant women at 36 weeks gestational age, who are not expected to have risk factors for preterm birth, n=150. Receives: 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. Receives: Other: Samples required from group 2 (procedure within observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- 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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Oct 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- SPD Development Company Limited, Borne Charity
- Responsible party
- Sponsor
- Investigators
- Natasha Singh, MRCOG, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590677
- Sponsor's protocol ID
- C&W19/037
- Acronym
- PREDICT
- Status last verified
- Aug 2021
- First submitted
- 21 Sep 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29880692Heng 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.
PubMed 18640661Heng 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.
PubMed 21167469
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Onset of Term and Preterm Labour (PREDICT)
- ClinicalTrials.gov ID
- NCT04590677
- Acronym / sponsor ID
- PREDICT / C&W19/037
- Conditions
- Preterm Pregnancy, Preterm Birth, Preterm Birth Complication, Preterm Premature Rupture of Membrane, Preterm Labor
- Keywords
- Preterm, Biomarker, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- SPD Development Company Limited, Borne Charity
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: 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. |
| Group 2 | – | Other: 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Group 1 |
| 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 | Other | Group 2 |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 29880692Ngo 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.
- Background: PubMed 18640661Heng 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.
- Background: PubMed 21167469Heng 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.
- Individual participant dataSharing planned: No
Related trials for Preterm Pregnancy
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Johnson, MRCOG contact
Natasha Singh, MRCOG principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Pregnancy and Preterm Birth, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Delivery Operations Manager (020 3315 6825, research.development@chewest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590677, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.