Iron deficiency anaemia in pregnancy Circulatory System
Conditions
Interventions
Two-arm parallel group, with 11,020 women being allocated in a 1:1 ratio to 200 mg ferrous sulphate once daily vs a matched placebo. The estimated duration of treatment is 34 weeks, from approximately
Sponsors
NHS Blood and Transplant
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy non-anaemic pregnant women of all parities (haemoglobin concentration [Hb] =110 g/l measured by the first-trimester blood profile) at booking or screening 2. A live fetus on a first-trimester ultrasound scan carried out for viability or dating. 3. 15 weeks + 6 days gestation or less 4. Aged 18 years and above 5. Able to give informed consent and willing to fulfil trial requirements
Exclusion criteria
Exclusion criteria: 1. Known haemoglobinopathies (women with haemoglobinopathy trait are still eligible) 2. Anaemia of any type, defined by British Society for Haematology guidelines 3. Severe gastrointestinal disease requiring ongoing treatment and potentially affecting tolerability of oral iron 4. Allergies to iron 5. Multiple pregnancies, given the higher iron demands 6. Known haemochromatosis 7. Recent red cell transfusion, within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 us | — |
Countries
United Kingdom
Outcome results
None listed