Table 3 Secondary outcomes
General |
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Rate of composite maternal complications (adapted from the International Collaboration to Harmonise Outcomes for Pre-eclampsia [40]: - Maternal mortality - Eclampsia - Stroke -Cortical blindness - Retinal detachment - Pulmonary oedema - Acute kidney injury - Liver capsule haematoma or rupture - Placental abruption - Postpartum haemorrhage - Raised liver enzymes - Haemolysis - Low platelets - Admission to the intensive care unit - Intubation/mechanical ventilation |
Gestational age at delivery |
Birthweight |
APGAR scores at 1 min and 5 min |
Neonatal seizures |
Neonatal respiratory morbidity |
Uncontrolled hypertension |
Pregnancy prolongation |
Rate of preeclampsia |
Rate of induction of labour |
Mode of delivery |
Postnatal readmission rate |
Second trimester mean systolic and diastolic BP |
Third trimester mean systolic and diastolic BP |
Postnatal mean systolic and diastolic BP |
Mean systolic and diastolic BP obtained in clinic setting |
Area under the BP curve |
Proportion of readings within target (< 140/90 mmHg) |
Episodes of severe hypertension > 160/100 mmHg |
Time to medication institution (weeks’ gestation) |
Number of medication dose escalations |
Healthcare utilisation |
Maternal blood or urine testing at the laboratory prior to birth admission |
Foetal cardiotocography |
Foetal ultrasound |
Number of outpatient visits - General practitioner - Antenatal clinic visit - Obstetric medicine clinic visits |
Number of medical, day, or maternity assessment unit visits |
Acute care area for urgent/emergent visit other than in labour - Emergency department - Birthing unit presentations |
Number of antenatal admission days prior to birth |
Feasibility and acceptability |
Compliance with remote monitoring (interventional arm only) |
Compliance with face to face consultations |
Number of phone calls from the investigator (interventional arm only) |
Recruitment rate |
Persistence with remote monitoring |
Quality of life and patient satisfaction |
EuroQol 5D survey |
State Trait Anxiety Inventory questionnaire |
Edinburgh Postnatal Depression Score questionnaire |
Investigator-designed remote monitoring feasibility surveys (interventional arm only) |
Qualitative interview with participants and clinicians (interventional arm only) |