It is Community-based cluster randomized trial and the study population are the pregnant women and live born neonates. The main outcome is preterm live birth and preterm pregnancy outcome. About 9000 pregnant women will enroll for the study where half of the subject in intervention arm and half in control arm.
The primary aim of this study is to determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) on preterm live birth in Sylhet district, Bangladesh.
The secondary aims of this study are:
1. To determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections on the:
a) Proportion of pregnancies with outcomes occurring prior to 37 weeks (late miscarriage, preterm still birth and preterm live birth); and
b) Proportion of babies with early onset neonatal sepsis.
2. To determine the prevalence of abnormal vaginal flora and urinary tract infections, including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh.
3. To evaluate the accuracy of simple, low-cost, point of care diagnostic tests for detecting bacterial vaginosis and urinary tract infections by community health workers in a rural, developing country setting.
Within this period of time the study has identified 4784 pregnant women among them 4437 met the study inclusion criteria who were enrolled. There are 2239 urine sample and 2051 vaginal swab have been collected with a very minimum refuse rate have 0.9% for urine and 1.3% for vaginal swab. 1085 point of care (POC) diagnostic test were performed by CHW. Among 2239 urine samples 171 (7.6%) were found as high burden UTI in lab culture result, 81 (3.5%) as intermediate growth whose has UTI symptoms were prescribe either Cefixim or Nitrofurontoin. Among 2051 vaginal swab smear 204 (10%) were bacterial vaginosis and 165 (8%) were intermediate flora were prescribe clindamycin. There are 2380 pregnancy outcome has occurred within this period of time among them 1806 (76%) were live birth, 133 (5.5%) still birth and 441 (18%) abortion or miscarriage.