Maternal Genitourinary Infections and Adverse Perinatal Outcomes
Bangladesh9,712 participantsStarted 2010-08
Plain-language summary
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.
Who can participate
Age range
1 Minute – 47 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All women who become pregnant in the study area will be eligible to participate in the trial. We will identify women with missed periods through monthly surveillance by health workers and identify pregnant women by positive pregnancy test conducted by CHWs. Thus enrollment may begin as soon as 5 weeks gestation and will continue until 19 weeks gestation. A sample of women who are enrolled early in gestation (\<12 weeks), will be considered for enrolment in the gestational age sub-study. The first CHW visit for screening for abnormal vaginal flora and urinary tract infection will occur after the initial enrollment between 13-19 weeks. Their infants will enrolled as well.
Exclusion Criteria:
Subjects will be excluded from the study if they have no recall or uncertain report of LMP (due to lactational amenorrhea, recent discontinuation of contraceptive or irregular menses), history of irregular bleeding due to injectable depoprovera, or history of severe chronic disease based on their self-reported history on a medical history checklist. For women reporting a missed period during pregnancy surveillance, the CHW will perform a urine pregnancy test to confirm the pregnancy and keep a log of all positive pregnancy tests and LMP.
Pregnant women who are uncertain or refuse to participate at the initial visit will be allowed time to consider and enroll at the next study visit if they still meet inclusion criteria. Women will be given information regarding the s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: 5 years
Trial details
NCT IDNCT01572532
SponsorJohns Hopkins Bloomberg School of Public Health