Hypertensive disorders in pregnancy Pregnancy and Childbirth
Conditions
Interventions
Randomisation is performed by a member of the trial team via the ‘Sealed Envelope’ service. Sites are randomised 1:1 to either standard care or the Clinical Decision Support Tool. The randomisation is
one for placental disorders (preeclampsia, stillbirth) and two for the risk of preterm birth (one at the beginning of pregnancy and the other during pregnancy if women present with threatened preterm
Sponsors
University of Bristol
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: All women and pregnant people booked into participating NHS Trusts for maternity care: 1. NHS Trust with an active maternity unit 2. NHS Trust with >3000 births per year 3. IT system available for outcome data extraction 4. Internet access in clinical areas (including community settings)
Exclusion criteria
Exclusion criteria: 1. Trust unwilling to participate 2. Trust using (or planning to use) the Fetal Medicine Foundation algorithm as part of their formalised standard care pathway
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypertensive disorders of pregnancy (pre-eclampsia or pregnancy-induced hypertension), measured at birth using: 1. The Clinical Decision Support Tool (intervention sites) 2. Extracts from local hospital systems (intervention and control sites) | — |
Secondary
| Measure | Time frame |
|---|---|
| Work Stream 1: the main trial 1. Stillbirth (fetal loss >24 weeks gestation) 2. Preterm birth (birth at 4000 g, LGA - birth centile >90th, and small for gestational age – SGA (birth centile <10th) measured at birth 2. Miscarriage (up to 23+6 weeks gestation) and stillbirth (death of baby after 24 weeks gestation before or during birth) measured at time of miscarriage or birth 3. Neonatal death (death =28 days of life) measured from birth to 28 days of life 4. Preterm birth (<34 and <37 weeks gestation of pregnancy) measured at birth 5. Gestational age (weeks) measured at birth 6. Neonatal complications: NICU admission; umbilical cord blood pH 7. Apgar score 8. Birth injury clavicle/humeral/skull fractures 9. Shoulder dystocia 10. Hypoglycaemia requiring NICU treatment 11. Respiratory distress 12. Fetal hyperbilirubinaemia measured at birth Maternal: 1. Antepartum haemorrhage measured at booking until birth 2. Gestational diabetes mellitus measured at booking until birth 3. Mode of delivery (LSCS – emergency/elective/ID –forceps/ventouse/SVD) measured at birth 4. Obstetric anal sphincter injury (OASIS) measured at birth 5. Spontaneous labour/ Induction of labour (gestation in weeks and days and reason) measured at birth 6. Planned and Emergency Caesarean section, measured at birth 7. Eclampsia measured from the booking appointment until 28 days after birth 8. Stroke measured from booking appointment until 28 days after birth 9. Pulmonary Oedema measured from the booking appointment until 28 days after birth 10. Acute Kidney Injury measured from the booking appointment until 28 days after birth 11. Maternal Death measured from the booking appointment until 28 days after birth 12. Postpartum haemorrhage measured from the booking appointment until 28 days after birth 13. Admission to ITU, intubation and ventilation measured from the booking appointment until 28 days after birth 14. Antenatal maternal hospital stay (days) 15. Postnatal maternal hospital stay (days) | — |
Countries
England, United Kingdom
Contacts
Public ContactChristy Burden
Outcome results
None listed