Cluster randomized crossover trial to evaluate point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings

Papua New Guinea Institute of Medical Research0 个研究点目标入组 4,600 人开始时间: 2016年7月10日最近更新: 2024年4月29日

适应症

试验速览

2019 Protocol article in https://wellcomeopenresearch.org/articles/4-53 protocol (added 10/02/2020) 2024 Results article in https://doi.org/10.1016/s2214-109x(24)00004-4 (added 17/04/2024)

•1. Aged 16 years or over at time of enrolment visit
•2. Attending first antenatal clinic visit
•3. Estimated gestational age 26 weeks or below based on obstetric ultrasound examination at first antenatal clinic visit
•4. Able to complete study informed consent procedures; to understand why the study is being carried out, and the potential risks and benefits associated with study participation
•5. Willing to undergo a clinical assessment including ultrasound examination; to provide urine or self-collected vaginal swabs for STI testing; and to comply with study follow-up procedures, including a postnatal visit within 72 hours of birth for the measurement of primary outcome data
•6. Live within approximately one hour drive of participating study clinic
•7. Able to provide reliable contact details to facilitate future community tracing and postnatal follow-up

•1. Severe, symptomatic anaemia identified during the enrolment visit that requires hospitalisation (Hb <6 g/dl accompanied by symptoms requiring urgent treatment)
•2. Permanent disability, that prevents or impedes study participation and/or comprehension (such that it is not possible to obtain informed consent to participate)

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