The Effect of Screening and Treatment of Asymptomatic Bacteriuria Every Trimester During Pregnancy on Incidence of Preterm Birth in Harare, Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Preterm birth
研究概览
简要总结
This study is evaluating whether screening of a pregnant woman for asymptomatic bacteriuria in each trimester for early detection and treatment of bacteriuria will reduce the incidence of preterm birth in Harare.
详细描述
Asymptomatic bacteriuria is common in pregnancy. If the disease is not detected early in pregnancy and treated it often progresses to an acute symptomatic disease, pyelonephritis which is associated with adverse pregnancy outcomes including preterm birth.
It is recommended that every woman be screened for asymptomatic bacteriuria by urine culture test at initial antenatal care visit so that the disease is if identified is treated early to prevent preventable complications of the disease in pregnancy. Culture test is expensive and therefore unavailable at several primary care settings especially in low resource settings where majority of pregnant women register and visit for antenatal care. In Zimbabwe antenatal care at primary care clinics is not including screening for asymptomatic bacteriuria. Majority who present with symptoms are empirically treated.
In this study the Griess nitrite test, an effective inexpensive screening test for asymptomatic bacteriuria is used. the test detects nitrite in urine which is associated with presence of nitrate reducing uropathogens, commonly the gram negative bacteria. All the positive samples will then be further tested by culture for bacteria identification, quantification and antibiotic sensitivity. A Randomized controlled trial research design is being used. participants are randomly allocated to intervention group or control group. Urine samples will be collected and tested 3 times for each recruited participant in the intervention arm. treatment will be initiated for positive result according to sensitivity test. Control group will only be subjected to routine existing antenatal care.
Participants will be recruited before 22 weeks gestation and followed on for second contact by 28 weeks and third contact by 36 weeks. Follow up will be stopped on delivery for noting gestation at delivery, whether preterm or term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator will not be aware of study group at analysis stage of results. The assessors of outcome will be blinded to study arm as they analyse data to reduce risk of bias.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women registering at study site.
- •Woman is able to identify her date of last menstrual period.
- •Gestation of pregnancy is between 6 and 22 weeks.
- •Woman is asymptomatic for bacteriuria
- •Woman voluntarily signs the consent form
排除标准
- •Pregnant woman ill and unwell
- •Pregnant woman unwilling to sign consent form
- •Woman who had antibiotic treatment 2 weeks before recruitment
- •Woman on long term antibiotic treatment
- •Woman who fails to identify date of last menstrual period
- •Woman symptomatic for urinary tract infection
结局指标
主要结局
Preterm birth
时间窗: Preterm birth will be calculated as gestation at birth of baby using date of birth and the first date of last menstrual period.
Preterm birth will be delivery of a baby before 37 complete weeks of gestation from the first date of last menstrual period. It will be sub-categorized as extremely preterm (\<28 weeks), very preterm (28 to \<32 weeks) and moderate to late preterm (32 to \<37 weeks).
次要结局
- Antibiotic sensitivity(These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening)
- Isolated uropathogen(These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening.)
- symptomatic bacteriuria(The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.)
- Gestation at birth(Gestation will be calculated at delivery of baby.)
研究者
Judith Rukweza, DPhil Student
Mrs
University of Zimbabwe