Malaria Neonatal Diseases Pregnancy and Childbirth
Conditions
Interventions
Azithromicyn
Sponsors
clinical research unit of nanoro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Being a pregnant woman between 16 and 32 weeks of pregnancy 2. At least 15 years old; and under 44 years old 3. Residence within the health facility catchment’s area, 4. Willingness to deliver at the health facility; 5. Willingness to adhere to the study protocol requirements; 6. Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions to the study drugs; 2. History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia; 3. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis; 4. Multiple pregnancies (i.e. twin/triplets); 5. Current cotrimoxazole prophylaxis or anti-retroviral therapy (ART); 6. Any significant ongoing condition that requires hospitalization, including severe malaria; 7. Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area; 8. Prior enrollment in the study or concurrent enrollment in another study; 9. Unable to take oral medication; 10. Clear evidence of recent treatment with artemisinin based combination treatment (ACT), SP or azithromycin during the first trimester of pregnancy, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of low birth weight (birth weight < 2500 g) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious and any adverse events ;Percentage of preterm delivered babies ;Rate of stillbirth ;Rate of miscarriage ;Mean birth weight ;Mean duration of gestation ;Percentage of low chest circumference at birth ;Percentage of low chest or head circumference at birth ;Percentage of acute neonate distress ;Mean neonate weight gain ;Mean maternal blood hemoglobin concentration at selection and delivery ;Percentage of women with mild, moderate or severe anemia at each point of hemoglobin assessment ;Percentage of women with peripheral blood malaria parasitaemia and mean parasite density at each month ;Mean number of maternal illness days during pregnancy and during neonate follow up period;Prevalence of maternal Chlamydia trachomatis, Neisseria gonorrhoea, and Treponema pallidum infection ;Incidence of maternal Chlamydia trachomatis, Neisseria gonorrhoea, and vaginal Treponema pallidum infection ;Prevalence of antibiotics resistant sexually transmitted infection ;Mean number of neonate illness days | — |
Countries
Burkina Faso
Contacts
Public ContactSeni Kouanda
National ethics committee
Outcome results
None listed