Fairness, poverty, and cost-effectiveness impact of two doses of corticosteroid injection given to pregnant women at risk of delivering before term

Not yet recruiting

Conditions: Respiratory distress syndrome of newborn,

Registration Number: CTRI/2023/07/055525

Lead Sponsor: Translational Health Science and Technology Institute

Brief Summary: 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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Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 1800

Inclusion Criteria

The study population includes pregnant women coming to the hospital for delivery in the late preterm period (enrolled in the main ACTION III trial) and their newborn.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of families with Catastrophic	Proportion of families with Catastrophic \| Healthcare Expenditure (CHE) due to in-patient \| and out-patient health care seeking for the \| ACTION III baby
Healthcare Expenditure (CHE) due to in-patient	Proportion of families with Catastrophic \| Healthcare Expenditure (CHE) due to in-patient \| and out-patient health care seeking for the \| ACTION III baby
and out-patient health care seeking for the	Proportion of families with Catastrophic \| Healthcare Expenditure (CHE) due to in-patient \| and out-patient health care seeking for the \| ACTION III baby
ACTION III baby	Proportion of families with Catastrophic \| Healthcare Expenditure (CHE) due to in-patient \| and out-patient health care seeking for the \| ACTION III baby

Secondary Outcome Measures

Name	Time	Method
Impoverishment	Enrolment to 28-days post-partum
Mean out-of-pocket expenditure	Enrolment to 28-days post-partum
Equity impact	Enrolment to 28-days post-partum
Cost per additional disability-adjusted life year	Enrolment to 28-days post-partum
Extended cost effectiveness	Enrolment to 28-days post-partum
Incremental Cost-Effectiveness Ratio	Enrolment to 28-days post-partum

Trial Locations

Locations (2): Translational Health Science and Technology Institute
🇮🇳
Faridabad, HARYANA, India
Vardhman Mahavir Medical College and Safdarjung Hospital
🇮🇳
Central, DELHI, India
Translational Health Science and Technology Institute
🇮🇳Faridabad, HARYANA, India
Dr Nitya Wadhwa
Principal investigator
01292876342
nitya.wadhwa@thsti.res.in