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Real-time PCR-assay in the delivery suite for determination of group B streptococcal colonization in a setting with risk-based antibiotic prophylaxis

Hakansson, Stellan; Källén, Karin LU ; Bullarbo, Maria; Holmgren, Per-Ake; Bremme, Katarina; Larsson, Asa; Norman, Margareta; Noren, Hakan; Ortmark-Wrede, Catharina and Pettersson, Karin, et al. (2014) In Journal of Maternal-Fetal & Neonatal Medicine 27(4). p.328-332
Abstract
Objective: Intrapartum antibiotic prophylaxis (IAP) reduces the incidence of neonatal early onset group B streptococcal infections. The present study investigated if an automated PCR-assay, used bedside by the labor ward personnel was manageable and could decrease the use of IAP in a setting with a risk-based IAP strategy. Methods: The study comprises two phases. Phase 1 was a multicenter, randomized, controlled trial. Women with selected risk-factors were allocated either to PCR-IAP (prophylaxis given if positive or indeterminate) or IAP. A vaginal/rectal swab and superficial swabs from the neonate for conventional culture were also obtained. Phase 2 was non-randomized, assessing an improved version of the assay. Results: Phase 1 included... (More)
Objective: Intrapartum antibiotic prophylaxis (IAP) reduces the incidence of neonatal early onset group B streptococcal infections. The present study investigated if an automated PCR-assay, used bedside by the labor ward personnel was manageable and could decrease the use of IAP in a setting with a risk-based IAP strategy. Methods: The study comprises two phases. Phase 1 was a multicenter, randomized, controlled trial. Women with selected risk-factors were allocated either to PCR-IAP (prophylaxis given if positive or indeterminate) or IAP. A vaginal/rectal swab and superficial swabs from the neonate for conventional culture were also obtained. Phase 2 was non-randomized, assessing an improved version of the assay. Results: Phase 1 included 112 women in the PCR-IAP group and 117 in the IAP group. Excluding indeterminate results, the assay showed a sensitivity of 89% and a specificity of 90%. In 44 % of the PCR assays the result was indeterminate. The use of IAP was lower in the PCR group (53 versus 92%). Phase 2 included 94 women. The proportion of indeterminate results was reduced (15%). The GBS colonization rate was 31%. Conclusion: The PCR assay, in the hands of labor ward personnel, can be useful for selection of women to which IAP should be offered. (Less)
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publication status
published
subject
keywords
Antibiotics, delivery, prophylaxis, real-time PCR, S. agalactiae
in
Journal of Maternal-Fetal & Neonatal Medicine
volume
27
issue
4
pages
328 - 332
publisher
Taylor & Francis
external identifiers
  • wos:000330068000002
  • scopus:84892760774
ISSN
1476-7058
DOI
10.3109/14767058.2013.818128
language
English
LU publication?
yes
id
08668048-1b96-44d3-8a50-9da4361b3536 (old id 4318490)
date added to LUP
2014-03-03 08:03:06
date last changed
2017-10-29 03:23:43
@article{08668048-1b96-44d3-8a50-9da4361b3536,
  abstract     = {Objective: Intrapartum antibiotic prophylaxis (IAP) reduces the incidence of neonatal early onset group B streptococcal infections. The present study investigated if an automated PCR-assay, used bedside by the labor ward personnel was manageable and could decrease the use of IAP in a setting with a risk-based IAP strategy. Methods: The study comprises two phases. Phase 1 was a multicenter, randomized, controlled trial. Women with selected risk-factors were allocated either to PCR-IAP (prophylaxis given if positive or indeterminate) or IAP. A vaginal/rectal swab and superficial swabs from the neonate for conventional culture were also obtained. Phase 2 was non-randomized, assessing an improved version of the assay. Results: Phase 1 included 112 women in the PCR-IAP group and 117 in the IAP group. Excluding indeterminate results, the assay showed a sensitivity of 89% and a specificity of 90%. In 44 % of the PCR assays the result was indeterminate. The use of IAP was lower in the PCR group (53 versus 92%). Phase 2 included 94 women. The proportion of indeterminate results was reduced (15%). The GBS colonization rate was 31%. Conclusion: The PCR assay, in the hands of labor ward personnel, can be useful for selection of women to which IAP should be offered.},
  author       = {Hakansson, Stellan and Källén, Karin and Bullarbo, Maria and Holmgren, Per-Ake and Bremme, Katarina and Larsson, Asa and Norman, Margareta and Noren, Hakan and Ortmark-Wrede, Catharina and Pettersson, Karin and Saltvedt, Sissel and Sondell, Birgitta and Tokarska, Magdalena and von Vultee, Anna and Jacobsson, Bo},
  issn         = {1476-7058},
  keyword      = {Antibiotics,delivery,prophylaxis,real-time PCR,S. agalactiae},
  language     = {eng},
  number       = {4},
  pages        = {328--332},
  publisher    = {Taylor & Francis},
  series       = {Journal of Maternal-Fetal & Neonatal Medicine},
  title        = {Real-time PCR-assay in the delivery suite for determination of group B streptococcal colonization in a setting with risk-based antibiotic prophylaxis},
  url          = {http://dx.doi.org/10.3109/14767058.2013.818128},
  volume       = {27},
  year         = {2014},
}