Maternal Genitourinary Infections and Adverse Perinatal Outcomes in Sylhet District, Bangladesh (MIST)

NCT01572532 NA COMPLETED

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. Hypothesis 1: Community-based screening and treatment of abnormal vaginal flora (Nugent score \>4) and urinary tract infections in early pregnancy (13-19 weeks) will reduce the population rate of preterm live birth by at least 15%. The secondary aims of this study are: * To determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections on the: * proportion of pregnancies with outcomes occurring prior to 37 weeks (late miscarriage, preterm still birth and preterm live birth); and * proportion of babies with early onset neonatal sepsis. * To determine the prevalence of abnormal vaginal flora and urinary tract infections, including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh. * 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.

Details

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	COMPLETED
Enrolment	9712
Start date	2010-08
Completion	2016-03-17

Conditions

• Maternal Infection Affecting Newborn

Interventions

• Screening treatment and referral

Primary outcomes

• Number of preterm births reduced by community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) — 5 years
  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.

Countries

Bangladesh