The Diagnosis and Treatment of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Pregnant Women to Prevent Adverse Neonatal Consequences.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery
研究概览
简要总结
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).
详细描述
In this study investigators are conducting a two-arm, cluster randomized trial to assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs). Investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive CT and NG testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. An additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. All participants will be tested for CT and NG at the first postnatal visit and those who test positive will be offered infant testing. Investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal CT/NG infection. This study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 15 years,
- •Currently pregnant,
- •Attending first ANC visit,
- •27 weeks gestation or less
- •Not currently experiencing CT/NG-related symptoms (determined by validated screening tool),
- •Not treated for CT/NG in the past 30 days,
- •Willingness to provide self-collected specimens for CT/NG testing (for the STI-testing group, this will take place at their first ANC visit, at another visit in their third trimester, and at postnatal care. For the standard of care group, samples will only be collected at postnatal care),
- •Willingness to return for a test of cure if CT/NG test is positive during antenatal care,
- •Will reside in Gaborone through the time of delivery and 1st postnatal visit,
- •Willingness to have neonates tested for CT/NG at their first postnatal visit,
- •Mentally competent to understand the informed consent.
排除标准
- •Not mentally competent to understand study procedures or give informed consent,
- •Individuals < 15 years,
- •Women who are not pregnant,
- •Pregnant women not attending their first antenatal visit,
- •Pregnant women at >27 weeks gestation
- •Pregnant women with current STI-related symptoms (will receive standard of care),
- •Treated for an STI in the past 30 days.
结局指标
主要结局
Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery
时间窗: This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.
Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms
次要结局
- Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery.(This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery.)
研究者
Jeffrey D Klausner
Clinical Professor
University of Southern California