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