Evaluating the diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences in Gaborone, Botswana: protocol for the Maduo study

Autor: Adriane Wynn, Aamirah Mussa, Rebecca Ryan, Emily Hansman, Selebaleng Simon, Bame Bame, Badani Moreri-Ntshabele, Doreen Ramogola-Masire, Jeffrey D. Klausner, Chelsea Morroni
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: BMC Infectious Diseases, Vol 22, Iss 1, Pp 1-15 (2022)
Druh dokumentu: article
ISSN: 1471-2334
61242454
DOI: 10.1186/s12879-022-07093-z
Popis: Abstract Background Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are extremely common sexually transmitted infections (STIs) that are associated with adverse birth and neonatal outcomes, and the risk of vertical transmission of CT and NG during delivery is high. The majority of CT and NG infections are asymptomatic and missed by the standard of care in most countries (treatment based on symptoms). Thus, it is likely that missed maternal CT and NG infections contribute to preventable adverse health outcomes among women and children globally. This study aims to assess the effectiveness of CT and NG testing for asymptomatic pregnant women to prevent adverse neonatal outcomes, understand the inflammatory response linking CT and NG infections to adverse neonatal outcomes, and conduct an economic analysis of the CT and NG testing intervention. Methods The Maduo (“results” in Setswana) is a prospective, cluster-controlled trial in Gaborone, Botswana to compare a near point-of-care CT and NG testing and treatment intervention implemented in “study clinics” with standard antenatal care (World Health Organization-endorsed “syndromic management” strategy based on signs and symptoms without laboratory confirmation) implemented in “standard of care clinics” among asymptomatic pregnant women. The primary outcome is vertical transmission of CT/NG infection. Secondary outcomes include preterm birth (delivery
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