跳至主要内容
临床试验/NCT03073538
NCT03073538已完成不适用

Screening of Gonococcal and Chlamydial Infections in the Third Trimester

Unity Health Toronto0 个研究点目标入组 1,691 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,691
主要终点
Rates of N. gonorrhoeae and C. trachomatis in the first trimester

研究概览

简要总结

Untreated maternal infection with gonorrhea and/or chlamydia can have serious complications in pregnancy and the neonatal period. In Ontario, routine screening for these infections is done in the first trimester of pregnancy, positive cases are treated with antibiotics, and all newborns are given antibiotic eye ointment within 24 hours of birth. Recently, the Canadian Pediatric Society recommended stopping universal prophylaxis for newborns, with instead, focus on screening and treatment of these infections in pregnancy. Given that these infections can occur at any time in pregnancy, and exposure at delivery provides a significant risk to infants, more information is needed about the rates of infection throughout pregnancy and health-care provider compliance with guidelines to make this change without undue risk. With this information optimal timing of testing can be evaluated.

详细描述

The primary objective of this study is to retrospectively examine the incidence rates of N. gonorrhoeae (NG) and C. trachomatis (CT) in the first and third trimester for the obstetrical population at St. Michael's Hospital over the course of six months. Secondary objectives include (1) feasibility of instituting third trimester screening for sexually transmitted infections, and (2) assessment of physician compliance with Canadian screening and treatment guidelines. This information will help us to deduce the optimal timing of screening for NG and CT in the obstetrical population at St. Michael's Hospital.

It is hypothesized that the incidence rates of both NG and CT infections will be low, but that much can be learned from the positive cases in terms of risk factors and optimal timing of screening. Further, the feasibility of screening in the third trimester will offer options for future guidelines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Rates of N. gonorrhoeae and C. trachomatis in the first trimester

时间窗: first trimester (1-12 weeks gestation)

To examine the incidence rates of N. gonorrhoeae and C. trachomatis in the first trimester of the obstetrical population at St. Michael's Hospital

Rates of N. gonorrhoeae and C. trachomatis in the third trimester

时间窗: third trimester (29-40 weeks gestation)

To examine the incidence rates of N. gonorrhoeae and C. trachomatis in the third trimester of the obstetrical population at St. Michael's Hospital

次要结局

  • Physician compliance with screening guidelines(first trimester (1-12 weeks gestation) and third trimester (29-40 weeks gestation))

研究者

申办方类型
Other
责任方
Sponsor

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