Methodology
- National, multicenter, two-arm, cluster (health facilities) randomized controlled trial, with cluster allocated on a 1:1 ratio.
- The study will be conducted in six states (Ebonyi, Edo, Gombe, Kano, Kwara, and Lagos) representing the six geopolitical zones in Nigeria.
- Eight (8) healthcare facilities will be selected from each state across all levels (tertiary, secondary and primary healthcare centers, making 48 targeted facilities in total for the clinical trial while 12 facilities different from the clinical trial sites will participate in the implementation study. In all, 60 healthcare facilities will participate in the AZIN-V study.
Study Population
Pregnant women in labor scheduled for vaginal delivery in government owned or high delivery private health facilities.
FLOWCHART FOR THE STUDY SITE DISTRIBUTION BY GEOPOLITICAL ZONE
Ethical Considerations:
Ethical approval will be obtained from the National Health Research and Ethics Committee of Nigeria and all the relevant Health Research and Ethics Committee (HRECs) of the six states as required. The trial will be registered on the ISRCTN Trial Registry. We will also obtain the National Agency for Food and Drug Administration and Control (NAFDAC) regulatory approval as deemed necessary for the medication to be deployed as intervention on the trial. All Investigators will have undertaken training on good clinical practice (GCP) and have valid certificates. The trial will follow GCP principles and guidelines. Our trained data collectors will also obtain, and document informed consent from all study participants before data collection.
Ethical Approvals:
Institutional
Lagos University Teaching Hospital (LUTH) – ADM/DSCST/HREC/APP/6325
Aminu Kano Teaching Hospital, Kano State – AKTH/MAC/SUB/12A/P-3/V1/3930
University of Ilorin Teaching Hospital, Kwara State – UITH/CAT/189/21B/581
Federal Medical Centre, Ebute-Metta, Lagos State – HREC 24-17
Federal Teaching Hospital, Gombe. – Approved
Irrua Specialist Teaching Hospital, Irrua Edo State – ISTH/HREC/20241507/605
Lagos State University Teaching Hospital, Ikeja, Lagos State – LREC/06/10/2571
Mile Four Hospital Abakaliki. – Approved
National Obstetric Fistula Centre, Abakaliki. – Approved
State Ministry of Health
Lagos State Ministry of Health – LSMH/4686/I/12
Kano State Ministry of Health – SHREC/2024/4837
Kwara State Ministry of Health – ERC/MOH/2022/05/300
Ebonyi State Ministry of Health – EBSHREC/04/036
Gombe State Ministry of Health – MOH/AADM/621/V.I/495
Edo State Ministry of Health – HA/737/24/A/2308328
National Health Research Ethics Committee (NHREC)
NHREC/01/01/2007-31/09/2024
National Agency for Food and Drug Administration and Control (NAFDAC)
Full Approval
Trial Registry
International Standard Randomised Controlled Trial Number – ISRCTN16415327