Prediction and prevention of preterm birth Pregnancy and Childbirth
Conditions
Interventions
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
clinical care: preterm surveillance methods and test results, e.g. infection screening, cervical length scan measurements, predictive biomarker tests, mental wellbeing screening tests, concomitant tre
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 d
Sponsors
King's College London
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Under 16 years old 2. Unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of mid-trimester pregnancy loss or preterm birth (PTB) before 37 weeks’ gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactJenny Carter
Outcome results
None listed