None listed
Conditions
Interventions
Intervention1: Azithromycin: 2 doses (1 gm per day for 2 consecutive days) during pregnancy at 20-24 weeks and 28-32 weeks
Control Intervention1: Calcium: 2 doses (500 mg per day for 2 consecutive day
Sponsors
Society for Applied Studies
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women more than 18 years of age 2. Less than or equal to 20 weeks gestation 3. living in low-middle income urban and periurban neighborhoods 4. At high risk of RTI with any of the following criteria a. Hb less than 10.5 g per dL by a laboratory test b. High CRP equal to or more than 10 mg per dl c. MUAC less than 24 cm OR BMI less than 18.5 kg per meter square OR BMI more than or equal to 30 kg per meter square d. History of of Diabetes or on anti-diabetic medications. e. Recurrent History of RTI or vaginal discharge (2 or more times) in last 12 months or any history of RTI or vaginal discharge in the last 6 months f. History of RTI or genital infection in the partner in last 12 months g. Past History of abortion, still birth, preterm or low birth weight delivery
Exclusion criteria
Exclusion criteria: 1. known history of heart disease 2. recent history of jaundice within last 3 months 3. severe illness leading to hospitalization in last 3 months 4. history of previous serious allergic reaction to drugs 5. H/O of antibiotic intake within last 4 weeks 6. ongoing episode of RTI (temporary exclusion) 7. h/o of cervical incompetency 8. not willing for institutional delivery in study hospital 9. those planning to go out of the study area within the next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm birthTimepoint: At birth (0 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Antimicrobial resistance in indicator bacteria in maternal and infant stool (sub- sample)Timepoint: 8 weeks post delivery;PSBI or sepsis, Growth, Cumulative use of Antibiotic use, Antibiotic free daysTimepoint: 8 weeks of infant age;Puerperal pyrexia or sepsisTimepoint: 8 weeks post delivery;Small and vulnerable newborns, stillbirthsTimepoint: At birth;Vaginal tract colonization by pathogenic organism (sub-sample)Timepoint: 32 weeks of gestation | — |
Countries
India
Contacts
Public ContactDr Bireshwar Sinha
Society for Applied Studies
Outcome results
None listed