Table 2 Specifically defined study outcomes
Effectiveness outcomes | ||||
|---|---|---|---|---|
Domain | Specific measurement | Specific metric | Method of aggregation | Time point |
Primary outcomes | ||||
 Maternal anaemia | Haemoglobin concentration in g/dl measured with a haematological auto-analyser | Value at 36 weeks’ gestation | Proportion of participants with Hb <11 g/dl | 36 weeks’ gestation |
 Preterm birth | Gestational age in weeks at delivery | Value at delivery | Proportion of preterm deliveries below 37 weeks 0 days gestation | Date of delivery |
Secondary maternal outcomes | ||||
 Maternal haemoglobin concentration | Haemoglobin concentration measured in g/dl with a haematological auto-analyser | Change in value at 4 weeks after enrolment | Mean change in haemoglobin concentration | Four weeks after enrolment |
 Maternal depression | Edinburgh Postnatal Depression Scale (EPDS) | Value at 36 weeks’ gestation and at 2 weeks postpartum | Proportion of participants with score ≥10 on the EPDS | 36 weeks’ gestation and 2 weeks postpartum |
 Severe adverse events (grade 3 or more) | Physician diagnosis or medical record documentation or report from participants | Value at any time point after enrolment | Proportion of participants with serious adverse events | Any time point after enrolment |
 Severe maternal events such as shock and sepsis | Physician diagnosis or medical record documentation | Value at any time point after enrolment | Proportion of participants with severe maternal events | Any time point after enrolment |
 Postpartum haemorrhage | Estimated blood loss in ml measured visually or by physician diagnosis of need for blood transfusion | Value at delivery | Proportion of participants with estimated blood loss >500 ml for vaginal delivery and >1000 ml for caesarean section/proportion of participants in need of blood transfusion | At delivery and within 24 h after |
Secondary infant outcomes | ||||
 Low birth weight | Baby’s weight in grammes at delivery | Value at delivery | Incidence of low birth weight (<2.5 kg) | At delivery |
   Stillbirth | Physician diagnosis, medical records, or report from a participant | Value at birth | Proportion of infants who die after 28 weeks’ gestation but before or during delivery | At delivery |
 Small-for-gestational age | Baby’s weight in grammes at delivery | Value at birth | Proportion of infants with birth weight below the 10th percentile for gestational age | At delivery |
 Neonatal death | Physician diagnosis or medical record documentation | Value within 28 days of delivery | Proportion of infants who die within 28 days of birth | From delivery to 28 days of life |
 Breastfed infants | Medical record documentation or report from participants | Value within 4 weeks of birth | Proportion of infants being breastfed at 1, 2, and 4 weeks of life | At 4 weeks after delivery |
 Early neonatal vaccinations | Medical record documentation | Value within 4 weeks of birth | Proportion of infants who have received Bacille–Calmette–Guerin, oral polio, and hepatitis within 4 weeks of birth | At 4 weeks after delivery |
Implementation outcomes and measures of cost-effectiveness | ||||
 Acceptability of intervention | Acceptability of Intervention measure (AIM) survey tool, FDGs, KIIs | Value at baseline and end of the study | Degree of acceptability of intervention by target stakeholders | End of study |
 Feasibility of intervention | Feasibility of Intervention Measure (FIM) survey tool, FDGs | Value at baseline and end of the study | Degree of feasibility of carrying out intervention by health care workers | End of study |
 Fidelity of intervention | Intervention procedure checklist | Value during study | Degree of fidelity of carrying out intervention by health care workers | End of study |
 Costs of intervention and control treatment | Survey, hospital records on cost of services | Value during study | Cost-effectiveness analysis for the study intervention from limited societal perspective | End of study |