Title of Study: A multi-country, multi-centre, two arm, parallel, double blind, placebo controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low resource countries to improve newborn out

Subtitle: ACTION-1 Trial

Protocol; Version: A65913; 1.10

Phase of Study: Phase 3;

Study Type: grant aided study

Approval Date:

Applicant Name: Dr Idowu Ayede

Address: Department of Obstetrics & Gynecology, University College Hospital, Ibadan

Date of Application: 2017-09-06

Applicant Name: Dr Idowu Ayede

Sponsor: World Health Organization

Address of Sponsor: Department of Reproductive Health and Research, Avenue Appia 20 12111 Geneva 27, Switzerland

Trial Sites: 1. University College Hospital, Ibadan 2. Mother and Child Hospital, Akure 3. State Specialist Hospital, Akure 4. Nyanya General Hospital, Abuja 5. Kubwa General Hospital, Abuja 6. Lagos state University Teaching Hospital, Ikeja 7. Lagos Island Maternity

Product Type: Biologics

Status of Approval: On-going