Abstract
BackgroundPremature babies suffer higher mortality and life-long disabilities. Asymptomatic bacteriuria (ASB) is postulated to induce preterm labor. Routine antenatal screening for ASB using urine culture is not feasible in most developing countries due to long turn-around time, user-unfriendliness, and lack of resources. The current parallel-group superiority pragmatic randomized controlled trial evaluated the effect of screening and evidence-based treatment of ASB using an optical-sensor-based point-of-care rapid-test on the incidence of preterm birth and low birthweight (LBW).Methods240 consenting asymptomatic pregnant women visiting an Indian tertiary public hospital for first antenatal check-up, irrespective of trimester/gravida, who had not consumed antibiotics in the preceding week, were enrolled from February-May 2017. Computer-generated concealed simple randomization allocation sequence was used to assign participants to intervention (120) and control arm (120). Usual hospital-care was provided in the control arm. In the intervention arm, urine samples were additionally screened for ASB using the rapid-test and the positive women were prescribed susceptible antibiotics. Blinded outcome assessors followed up with women post-delivery. The study was registered with the Clinical Trials Registry-India (CTRI/2016/09/007240).Findings213 participants were analyzed (intervention: 103, control: 110). 21 women were found positive for ASB and prescribed pathogen-specific antibiotics. The incidence of preterm birth/LBW in intervention arm (n = 27) was lower than control arm (n = 45) by 14·7% (95% CI: 2·2–27·2); RR: 0.64, (95% CI: 0·43–0·95); p = 0·023, X2=5·13.InterpretationRapid-test-guided treatment for ASB reduced the incidence of preterm birth/LBW in a pragmatic setting without any adverse event.FundingDepartment of Biotechnology, Government of India.
Highlights
Pregnant women are susceptible to colonization of the urinary tract like asymptomatic bacteriuria (ASB), or urogenital infections, such as bacterial vaginosis, vulvovaginal candidiasis, and urinary tractResearch in contextEvidence before this studyConventional urine culture was not shown to be useful in mass screening of pregnant women for asymptomatic bacteriuria (ASB)
As per WHO definition, preterm birth is defined as babies born alive before 37 completed weeks of pregnancy [5], while low birthweight (LBW) is defined as weight at birth being less than 2500 gs [25]
The confidence interval ranging from 2¢2% to 27¢2% less cases of preterm birth or LBW in intervention arm, indicates a clinically important effect of early diagnosis of ASB and its subsequent treatment with appropriate antibiotics
Summary
Pregnant women are susceptible to colonization of the urinary tract like asymptomatic bacteriuria (ASB), or urogenital infections, such as bacterial vaginosis, vulvovaginal candidiasis, and urinary tractResearch in contextEvidence before this studyConventional urine culture was not shown to be useful in mass screening of pregnant women for asymptomatic bacteriuria (ASB). No study had measured the effectiveness of a point-of-care test on reduction of preterm birth and low birthweight (LBW) in a real-life situation. The study showed the effectiveness of use of a rapid point-ofcare test during antenatal checkup in reducing preterm birth and LBW by informing clinicians regarding ID & AST for ASB within four hours. The study proved feasibility of using a rapid, user-friendly, affordable, and valid test for mass screening of ASB in pregnant women. The current parallel-group superiority pragmatic randomized controlled trial evaluated the effect of screening and evidence-based treatment of ASB using an optical-sensor-based point-of-care rapid-test on the incidence of preterm birth and low birthweight (LBW). Urine samples were screened for ASB using the rapid-test and the positive women were prescribed susceptible antibiotics.
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