Efficacy of oral azithromycin in pregnant women living-in low-income neighborhoods with high-risk of reproductive tract infections to prevent preterm birth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Preterm birth
研究概览
简要总结
India is amongst the countries with the highest prevalence of preterm birth and contributes to around one-fifth of all preterm births, globally. Infections of the reproductive tract, colonisation of fetal membranes and associated maternal inflammatory immune response is recognized as a major trigger in most cases of preterm birth. The risk of reproductive tract infections (RTI) is higher in women living in low-income neighborhoods with poor sanitary conditions and in those with anemia, malnutrition, diabetes, or poor menstrual hygiene. Azithromycin is a broad-spectrum macrolide antibiotic with anti-inflammatory properties and is commonly used for symptomatic reproductive tract infections. Previous evidence from African trials in malaria holoendemic settings suggest that 2-dose azithromycin in the antenatal period can substantially reduce preterm births. It is unclear whether the intervention works in South Asian settings. Our primary study objective is to evaluate whether two doses of oral azithromycin (2 g) during the antenatal period, after first trimester (20-24 weeks) and at 28-32 weeks of gestation in Indian women living-in low-income neighborhoods with high-risk of reproductive tract infections can substantially prevent preterm birth and birth of other small vulnerable infants. We will also evaluate the two doses of azithromycin is associated with reduction of neonatal sepsis, puerperal pyrexia, or sepsis in the mothers, need for antibiotic use during the first 2 months of birth, any increase in the cumulative incidence of phenotypic macrolide resistance in women and children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women more than 18 years of age
- •living in low-middle income urban and periurban neighborhoods
- •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.
- •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.
排除标准
- •known history of heart disease
- •recent history of jaundice within last 3 months
- •severe illness leading to hospitalization in last 3 months
- •history of previous serious allergic reaction to drugs
- •H/O of antibiotic intake within last 4 weeks
- •ongoing episode of RTI (temporary exclusion)
- •h/o of cervical incompetency
- •not willing for institutional delivery in study hospital
- •those planning to go out of the study area within the next 6 months.
结局指标
主要结局
Preterm birth
时间窗: At birth (0 days)
次要结局
- Small and vulnerable newborns, stillbirths(At birth)
- PSBI or sepsis, Growth, Cumulative use of Antibiotic use, Antibiotic free days(8 weeks of infant age)
- Vaginal tract colonization by pathogenic organism (sub-sample)(32 weeks of gestation)
- Puerperal pyrexia or sepsis(8 weeks post delivery)
- Antimicrobial resistance in indicator bacteria in maternal and infant stool (sub- sample)(8 weeks post delivery)
研究者
Dr Bireshwar Sinha
Society for Applied Studies