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The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.
We are conducting a randomized, controlled clinical trial in Soweto, South Africa to evaluate the efficacy of 0.5% chlorhexidine wipes of the birth canal during labour and of the infant at birth in reducing 1) vertical transmission of leading pathogenic bacteria from mother to child during labour and delivery, and 2) incidence of neonatal sepsis and maternal peripartum infection, in comparison to external genitalia sterile water wipes. In conjunction with this, we will compare vaginal carriage of bacteria commonly associated with neonatal sepsis and maternal peripartum infection among HIV-infected and non-infected pregnant women who deliver at the only public hospital in Soweto, and will characterize the burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in this population by conducting active prospective surveillance.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Infant, Newborn, Diseases
Chlorhexidine, Birth canal wipe, sterile water external genital wipe
Chris Hani Baragwanath Hospital
Centers for Disease Control and Prevention
Published on BioPortfolio: 2014-08-27T03:52:14-0400
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Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions. Sterile...
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The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infec...
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To accurately measure external auditory canal (EAC) dimensions by high resolution computed tomography (CT), and compare results with a traditional method of EAC measurement.
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The outer part of the hearing system of the body. It includes the shell-like EAR AURICLE which collects sound, and the EXTERNAL EAR CANAL, the TYMPANIC MEMBRANE, and the EXTERNAL EAR CARTILAGES.
An oval semitransparent membrane separating the external EAR CANAL from the tympanic cavity (EAR, MIDDLE). It contains three layers: the skin of the external ear canal; the core of radially and circularly arranged collagen fibers; and the MUCOSA of the middle ear.
The genital canal in the female, extending from the UTERUS to the VULVA. (Stedman, 25th ed)
A condition of sexual ambiguity in which the individual (pseudohermaphrodite) possesses gonadal tissue of one SEX but exhibits external PHENOTYPE of the opposite sex. Female pseudohermaphroditism is an individual with XX karyotype, normal development of OVARIES and internal reproductive tract, but with ambiguous or virilized external GENITALIA. Male pseudohermaphroditism is characterized by the presence of a Y CHROMOSOME and TESTES, but the genital tract and external genitalia are ambiguous or completely female.
A putative protein interaction module, approximately 70 amino acids long, that forms a small five-helix bundle with two large interfaces which may homo- and hetero-oligomerize, or bind non-sterile-alpha motif targets. The sterile alpha motif is present in a wide variety of eukaryotic proteins that function in diverse biological processes.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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