PCN-CRP: a programme for improving the prediction and prevention of preterm birth and women’s experience of care
| ISRCTN | ISRCTN21809678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21809678 |
| IRAS number | 344400 |
| Secondary identifying numbers | CPMS 65239 |
- Submission date
- 18/09/2025
- Registration date
- 19/09/2025
- Last edited
- 19/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Preterm birth is the leading cause of neonatal death and morbidity worldwide. This has significant repercussions for individuals and their families and the economic costs to society are considerable. The Preterm Clinical Network Cohort Research Programme (PCN-CRP) is a series of studies aiming to reduce preterm birth and the problems it can cause. These studies will investigate tests to predict preterm birth, treatments to prevent it, and how to improve outcomes for babies and women’s experience of care.
Who can participate?
Pregnant women aged 16 years or above who are at risk of preterm birth, either because they have known risk factors, e.g. have had an early baby before, or those who are experiencing symptoms of threatened preterm labour.
What does the study involve?
Participants will be asked to agree to information being collected from their maternity record. This will include information about the participant (e.g. age, ethnicity), any previous pregnancies or medical conditions, the care received in this pregnancy and the pregnancy outcomes, e.g. whether or not she has her baby early.
What are the possible benefits and risks of participating?
Taking part in this programme is unlikely to have direct benefit for the participant or her current pregnancy. What we learn, however, might help us to improve care for her in any future pregnancies as well as for other women, and reduce the number of babies being born too early. The participant’s care will not be affected by taking part and no treatments are being tested so there are no risks or disadvantages, other than the time required to read the information sheet/s and sign the consent form/s.
Where is the study run from?
King’s College London and Guy’s & St Thomas’ NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2024 to March 2028
Who is funding the study?
Tommy’s (the pregnancy and baby charity) (UK)
Who is the main contact?
Dr Jenny Carter, jenny.carter@kcl.ac.uk
Contact information
Public, Scientific
Department of Women and Children's Health
10th Floor, North Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
 ORCID ID |
0000-0003-2550-6465 |
|---|---|
| Phone | +44 (0)2071887188 |
| jenny.carter@kcl.ac.uk |
Principal Investigator
Department of Women and Children's Health
10th Floor, North Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| ORCID ID |
0000-0001-5273-3132 |
|---|---|
| Phone | +44 (0)2071883639 |
| andrew.shennan@kcl.ac.uk |
Study information
| Study design | Multi-centre prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention, Screening, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Preterm Clinical Network Cohort Research Programme (PCN-CRP) |
| Study acronym | PCN-CRP |
| Study objectives | The Preterm Clinical Network Cohort Research Programme (PCN-CRP) is a series of studies aiming to reduce preterm birth and the problems it can cause. These studies will investigate tests to predict preterm birth, treatments to prevent it, and how to improve outcomes for babies and women’s experience of care. The programme will be carried out in partnership with Tommy’s National Centre for Preterm Birth Research and the UK Preterm Clinical Network (UKPCN). This is a network of doctors, midwives and scientists who are working together to prevent the problems associated with preterm birth. Women at risk of preterm birth will be asked to take part in one or more of the programme’s individual studies (sub-studies). Although more sub-studies will be added in the future, the first four will investigate: 1. How urine infection affects the chances of preterm birth 2. Whether different characteristics (e.g. position and measurements) of previous caesarean section scars, seen by ultrasound, can help to predict the chances of preterm birth and which treatments would work best 3. How many women at risk of preterm birth suffer from poor mental health, what additional support they are offered and whether they accept it 4. New factors to include in QUiPP, a preterm birth prediction and decision support tool. |
| Ethics approval(s) |
Approved 17/03/2025, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 972 25 04; leedswest.rec@hra.nhs.uk), ref: 25/YH/0008 |
| Health condition(s) or problem(s) studied | Prediction and prevention of preterm birth |
| Intervention | Prospective collection of clinical data for use in sub-studies aiming to improve prediction and prevention of preterm birth. Following informed consent, data will be collected by attending clinician or research midwives and will include: participant background: demographic characteristics, risk factors, medical and obstetric history; clinical care: preterm surveillance methods and test results, e.g. infection screening, cervical length scan measurements, predictive biomarker tests, mental wellbeing screening tests, concomitant treatments; pregnancy outcomes. Data will be stored on the PCN Database (https://www.medscinet.net/ukpcn). If the participant consents to possible long-term follow-up of her own health or her child’s health and developmental status as part of future approved research, this could potentially occur at any time in the future, unless she withdraws her consent. |
| Intervention type | Other |
| Primary outcome measure | The occurrence of mid-trimester pregnancy loss or preterm birth (PTB) before 37 weeks’ gestation |
| Secondary outcome measures | The secondary outcomes that relate to all sub-studies are listed below: 1. Preterm birth before 30 and 34 weeks 2. Mid-trimester loss (14-23 weeks) 3. Gestation at birth 4. Onset of labour (e.g. spontaneous, induced, pre-labour CS) 5. Preterm intervention use (e.g. cerclage, progesterone, vaginal pessary) 6. Antenatal corticosteroid use for fetal lung maturation 7. Magnesium sulphate use for fetal neuroprotection 8. In-utero transfer (for neonatal cot availability) 9. Admission to intensive care unit (mother and neonate) 10. Length of hospital stay (mother and neonate) 11. Infection (mother and neonate) 12. Perinatal death (i.e. stillbirth or neonatal death) 13. Maternal death Sub-study 1: results of asymptomatic urine screening (dipstick or culture) at booking or first appointment when this is carried out in pregnancy; results of any subsequent urine culture for suspicion of urinary tract infection, with symptoms and treatments will be recorded. This could be at any timepoint in the participant’s pregnancy. Sub-study 2: caesarean section scar characteristics (if seen on transvaginal ultrasound scan) including distance from internal os and dimensions of niche, if observed, will be recorded. This could be at any timepoint in the participant’s pregnancy. Sub-study 3: mental wellbeing will be measured using the validated instruments PHQ9, GAD7, PROMIS-10, at all preterm clinic appointments. This could be at any timepoint in the participant’s pregnancy. Sub-study 4: results of any preterm birth prediction test (including, but not restricted to: vaginal swab tests, such as Actim Partus, transvaginal ultrasound for measurement of cervical length, cervical stiffness measured using the Pregnolia device). This could be at any timepoint in the participant’s pregnancy. |
| Overall study start date | 29/04/2024 |
| Completion date | 31/03/2028 |
Eligibility
| Participant type(s) | Patient, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 0 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 13027 |
| Key inclusion criteria | Pregnant women will be eligible for the programme if they: 1. Have risk factors for preterm birth: previous preterm or mid-trimester loss, history of invasive cervical surgery, history of in-labour caesarean section, uterine anomaly, any other factor considered a risk factor for preterm birth by clinical expertise or national guidelines, or 2. Are experiencing symptoms of threatened preterm labour 3. Are eligible for at least one of the sub-studies as defined in protocol appendices 21.1-4 4. Are willing and able to give informed consent 5. Are aged 16 years or above |
| Key exclusion criteria | 1. Under 16 years old 2. Unwilling to give informed consent |
| Date of first enrolment | 22/09/2025 |
| Date of final enrolment | 31/03/2028 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
NW1 2BU
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Manchester
M13 9WL
United Kingdom
Tonna Uchaf
Tonna
Neath
SA11 3LX
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Birmingham
B4 6NH
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
729 the Ridge
St. Leonards-on-sea
TN37 7PT
United Kingdom
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Crown Street
Liverpool
L8 7SS
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
Stott Lane
Salford
M6 8HD
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Lewisham High Street
London
SE13 6LH
United Kingdom
Cumberland Infirmary
Infirmary Street
Carlisle
CA2 7HY
United Kingdom
Sponsor information
University/education
Room 8.11, 8th Floor
Melbourne House
44-46 Aldwych
London
WC2B 4LL
England
United Kingdom
| Phone | +44 (0)2078487306 |
|---|---|
| vpri@kcl.ac.uk | |
| Website | kcl.ac.uk |
Hospital/treatment centre
R&D Office
16th Floor Tower Block
Guy’s Hospital
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)20 7188 7188, ext 54426 |
|---|---|
| gstt.randd@nhs.net | |
| Website | https://www.guysandstthomas.nhs.uk/ |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/03/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Findings will be shared through medical literature, as well as the wider media and PPI social networks, and ultimately will inform further research and national clinical guidelines. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request. Where participants have explicitly consented to their data being shared for future research purposes, anonymised data may be shared with third party researchers subject to review and approval of the Preterm Clinical Network (PCN) Database Access Committee. This committee comprises clinical preterm birth expert members of the UK Preterm Clinical Network and a patient representative with lived experience. The committee is governed by procedures stipulated in the PCN Database protocol and approved by Research Ethics Committee (REC 22/ES/0001; IRAS 308157). These include submission of detailed application form by third party researchers and committee review of research team and project. If approved, anonymised data is transferred by secure means following execution of data sharing agreements between parties (i.e. KCL, researcher institution and contributing Data Collection Centres). |
Editorial Notes
19/09/2025: Internal review.
18/09/2025: Study's existence confirmed by the Yorkshire & The Humber - Leeds West Research Ethics Committee.
