Prevention of maternal sepsis among pregnant women undergoing vaginal birth Pregnancy and Childbirth
Conditions
Interventions
The AZIN-V study will be a cluster-randomized controlled trial with parallel assignment using a 1:1 allocation ratio for both the clinical trial and implementation study.
A total of 60 study sites w
Sponsors
University of Lagos
Eligibility
Sex/Gender
Female
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 26/11/2025: 1. Pregnant women with a live or stillborn singleton or twin pregnancy of at least 24+0 weeks gestation in the active phase of the first stage of labour (cervical dilatation of 4cm or more) or early (non-pushing) phase of the second stage of labour. 2. Pregnant women admitted in labour to the selected health facilities following spontaneous or induced labour with a planned vaginal birth. _____ Previous key inclusion criteria: 1. Pregnant women with singleton or multiple pregnancies of at least 24+0 weeks GA in labour including those in the first stage with cervical dilatation of =7 cm or in the second stage of labour 2. Admitted in labour to the participating health facilities for spontaneous or induced vaginal birth 3. Women presenting with stillbirth will also be eligible since they are at risk of postpartum sepsis
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 26/11/2025: 1. Pregnant women of gestational age 38°C. 5. Pregnant women with history of use of a macrolide antibiotic in the previous three days. 6. Pregnant women with known allergy to azithromycin, its excipients, or other macrolide antibiotics. 7. Pregnant women with known history of cardiac disease (such as cardiac arrhythmia or cardiomyopathy). 8. Pregnant women with planned caesarean birth. _____ Previous key exclusion criteria: 1. Gestational age 38°C with no other explanation 5. Has evidence of macrolide antibiotic use in the previous three days 6. Known allergy to azithromycin or its excipients or other macrolides 7. Known to have an arrhythmia or a known history of cardiomyopathy 8. Planned caesarean delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures for the clinical trial: 1. Incidence of maternal sepsis is measured using clinical and laboratory parameters at four timepoints after childbirth: day 3, 2 weeks, 4 weeks, and 6 weeks post-delivery. 2. Cost-effectiveness is measured using Incremental Cost-Effectiveness Ratio (ICER) at baseline and 6 weeks post-delivery: additional cost per unit of health gain with azithromycin compared to the usual care for individual participants as a component of the sepsis prevention protocol in healthcare facilities. Primary outcome measure for the implementation study: 1. Fidelity is measured using health facility records and observation checklist during implementation and endline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures for the clinical trial: 1. Incidence of culture-confirmed maternal sepsis is measured using microbiological positive culture results at timepoints within 6 weeks of childbirth 2. Number of new prescriptions of antibiotics for a specific maternal infection (including bacterial vaginosis, chorioamnionitis, endometritis, abdominal or pelvic abscess, mastitis or breast abscess, pneumonia, or pyelonephritis or acute cystitis) measured using medical records and questionnaire at 6 weeks of childbirth 3. Incidence of neonatal sepsis within 28 days of birth is measured using clinical and laboratory parameters at time points within 28 days of birth 4. Incidence of stillbirth measured using questionnaire at baseline 5. Incidence of neonatal death measured using questionnaire at day 29 of birth 6. Duration of initial hospital stay for neonate, defined as the time of delivery until the time of hospital discharge, measured using medical records and questionnaire at day 29 of birth 7. Incidence of neonatal readmission is measured using medical records and questionnaire at day 29 of birth 8. Duration of hospital stay for mother is measured using medical records and questionnaire at 6 weeks after childbirth 9. Incidence of maternal readmission is measured using medical records and questionnaire at 6 weeks after childbirth 10. Incidence of adverse drug events (fainting or dizziness, nausea, vomiting, diarrhoea, and dyspepsia) and other reported side effects measured using medical records and questionnaire at 2 weeks after childbirth 11. Incidence of secondary post-partum haemorrhage, defined as excessive bleeding requiring surgical intervention or blood transfusion from 24 hours after delivery till 6 weeks postpartum, measured using medical records and questionnaire at 6 weeks after childbirth Secondary outcome measures for the implementation study: 1. Reach is measured using health facility records and observation checklist during implementation and endli | — |
Countries
Nigeria
Contacts
Public ContactBosede;Christian C Afolabi;Makwe
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Outcome results
None listed