Prevention of anaemia with oral iron supplementation

Approved 17/11/2023, North of Scotland Research Ethics Committee 1 (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, United Kingdom; +44 (0)1224 558458; gram.nosres@nhs.scot), ref: 23/NS/0123

A composite outcome of the proportion of pregnancies with pre-term birth (<37 completed weeks gestation), stillbirth (at 24 weeks gestation or above), neonatal death (up to 28 days) and small for gestational age (SGA) (<10th centile sex-specific weight for age, defined by UK growth charts)

Secondary outcomes relating to the mother are as follows:
1. Components of the composite primary outcome measured using case report form (CRF):
1.1. Pre-term birth (<37 completed weeks gestation)
1.2. Small for gestational age (<10th centile sex-specific weight for age)
1.3. Stillbirth (at 24 weeks gestation or above)
1.4. Neonatal death (up to 28 days)
2. Proportion of women developing anaemia during pregnancy measured using CRF
3. Mean transitions in haemoglobin measured using CRF from recruitment to 28 weeks & birth
4. Proportion of women with primary postpartum haemorrhage (PPH) measured using CRF
5. Proportion of women requiring red cell transfusions measured using CRF prior to discharge but not more than 48 hours post-birth
6. Proportion of women receiving an iron infusion measured using CRF prior to discharge and up to 6 weeks after birth
7. Proportion of women with an infection and or sepsis measured using CRF before discharge and up to 6 weeks after birth
8. Proportion of women breastfeeding or providing breast milk for pre-term infant or baby measured using CRF at discharge from maternity care and at 6 weeks
9. Proportion of women with postpartum depression/psychosis measured using CRF at 6 weeks post-birth
10. Mean adherence to medication measured using the MGL-4 score at 28 weeks
11. Health-related quality of life (HRQoL) measured using EQ-5D-5L at baseline, 28 weeks and at 6 weeks post-birth
12. Healthcare utilisation measured using CRF over the trial period

Secondary outcomes relating to the infant are as follows:
1. Mean birthweight measured using CRF
2. Mean gestation at birth measured using CRF
3. Apgar score at 5 minutes post-birth
4. Proportion of infants treated for possible neonatal early-onset infection, measured using CRF up to 6 weeks post-birth
5. Proportion of infants with culture-positive neonatal early-onset infection, measured using CRF up to 6 weeks post-birth
6. Proportion of infants admitted to neonatal/transitional care, measured using CRF up to 6 weeks post-birth
7. Healthcare utilisation including initial hospital stay, subsequent hospital readmissions, measured using CRF up to 6 weeks post-birth

Secondary outcomes relating to the process evaluation (WS4):
1. Intervention fidelity (i.e. whether intervention delivered and engaged with as planned) over the trial period, measured using website analytics, surveys, interviews, Medication Adherence Report Scale (MARS-5)
2. Intervention acceptability via survey and interviews at 28 weeks and +6 weeks delivery
3. Intervention feasibility via survey and interviews at 28 weeks and +6 weeks delivery