Trial of the Use of Antenatal Corticosteroids in Developing Countries

Condition(s) targeted: Preterm Birth

Intervention: i) Diffusing recommendations for antenatal corticosteroids use to healthcare providers (Behavioral)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Overall contact:
Marion Koso-Thomas, MD, Phone: 301-435-6873, Email: kosomari@mail.nih.gov

Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of Celestone® administration to eligible women.

Official title: Trial of the Use of Antenatal Corticosteroids in Developing Countries

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Neonatal mortality at 28 days in low birth weight infants (as a proxy measure for prematurity)

Detailed description: One of the United Nations Millennium Summit goals is to reduce the deaths of children <5 years by two-thirds for 2015 (UN, 2000). Given that 38% of all under-five deaths worldwide occur in the first four weeks of life, the goal seems unattainable unless a significant fraction of the neonatal deaths are prevented (Darmstadt et al., 2005). Thus, the provision of health care during the perinatal period in developing countries is a top priority. Preterm birth is a major cause of neonatal mortality, currently responsible for 28% of the deaths overall. As the contribution of preterm birth to neonatal deaths is well above 50% (MacDorman et al., 2005) in middle and high income countries, it is expected that as low income countries improve their development, the relative importance of this cause will increase. One of the most powerful perinatal interventions to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Cluster-level inclusion criteria

- At least 200 deliveries per year

- Antenatal corticosteroid use in preterm deliveries below 30%

Participant-level inclusion criteria

For outcome assessment:

All pregnant women that are considered emancipated according to country standards, that reside in study clusters and that provide informed consent for data collection purposes will be eligible for enrollment.

The following subgroups will be followed after delivery:

- 7-day follow-up All live-born neonates and their mothers in study clusters,

irrespective of place of delivery.

- 28-day follow-up Live-born neonates that are low birth weight according to

country-specific weight limits (see outcome assessment section), and their mothers

Exclusion Criteria:

- There will not be any specific exclusion criteria for clusters or participants.

Marion Koso-Thomas, MD, Phone: 301-435-6873, Email: kosomari@mail.nih.gov

Starting date: March 2011
Last updated: March 9, 2010