Preterm birth (PTB) is a global public health issue and the single largest contributor to the

high neonatal mortality seen in many Low and Middle Income Countries (LMICs). There is

currently a lack of clarity on clinical benefits of Antenatal Corticosteroids (ACS) use in the

late preterm period (34-<37 weeks of gestation). Therefore, ACTION III, a multi-country,

multi-centre, three-arm, parallel group, double-blind, placebo-controlled, randomised trial

is being conducted in five LMICs to evaluate two ACS regimens, conventional dose

dexamethasone phosphate and low dose betamethasone phosphate, given to women

with a high probability of PTB in the late preterm period to improve neonatal outcomes (CTRI/2021/03/032429).

However, efficacy data from standard RCTs provide little guidance on how to improve

treatment coverage of proven interventions among worse-off populations. Hence, the

equity and financial impact analysis will be done for a subset of the ACTION III Trial

participants.

Equifinance ACTION III will be embedded within the main ACTION III trial. Women at high

risk of late preterm birth i.e. between 34+0 and 36+6 weeks will be recruited in the trial.

The participant would receive one of the following intervention: Dexamethasone

Phosphate 6mg im q12h x 4 doses (or) Betamethasone Phosphate 2mg im q12h x 4

doses (or) Normal saline im q12h x 4 doses as part of the parent trial. Follow up of the

mother-infant dyad will be done until till 28-days of life. For the equity extension of the trial,

household consumption will be evaluated at the time of recruitment for each trial

participant and the expenses due in-patient and out-patient healthcare seeking will be

documented at two timepoints; discharge after delivery and 28 day after birth.

The primary outcome is the proportion of families with Catastrophic Healthcare

Expenditure (CHE) due to in-patient and out-patient health care seeking for the ACTION

III baby Additionally, Financial risk protection gains [number of CHE cases or poverty

cases averted by the intervention], cost-effectiveness [quantifying amount of health gain

per $ spent] and equity impact [measuring the extent to which the intervention benefits the

less privileged] will also be evaluated.

Considering the proportion of families experiencing CHE due to care seeking for the

mother and her baby from recruitment to 28-day of life as 25%, a sample of 565

participants in each arm will give us 80% power to estimate a 30% reduction in relative

risk of CHE at a two-sided alpha of 0.025 using a chi-square test. Thus, the total sample

size of the study will be 1695. The total sample size for the parent study at India-New

Delhi is 1800 and all of them will be included for this objective.

Such evaluations will have multi-fold advantages: 1) allow policy makers to allocate scarce

health care resources in a way that balances multiple health policy objectives, and 2)

captures a fuller picture of the expected benefits and dis-benefits from an intervention,

and as a result it facilitates a well-informed decision making.

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