External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes

Objectives: To prospectively validate the diagnostic performance of a non-invasive point-of-care tool (Rapid IAI System), including vaginal alpha-fetoprotein and interleukin-6, to predict the occurrence of intra-amniotic inflammation in a Spanish cohort of patients admitted with a diagnosis of prete...

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Autores: Cobo Cobo, Maria Teresa, Burgos Artizzu, Xavier P., Ferrero Martinez, Sílvia, Balcells, Judith, Bosch, Jaime, Gené, Amadeu, Murillo Bravo, Clara, Rueda, Claudia, Boada, David, Sánchez Antón, Maria Teresa, Kacerovsky, Marian, Jacobsson, Bo, Palacio, Montse
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/219980
Acceso en línea:https://hdl.handle.net/2445/219980
Access Level:acceso abierto
Palabra clave:Part prematur
Líquid amniòtic
Embarassades
Premature labor
Amniotic liquid
Pregnant women
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spelling External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranesCobo Cobo, Maria TeresaBurgos Artizzu, Xavier P.Ferrero Martinez, Sílvia Balcells, JudithBosch, JaimeGené, AmadeuMurillo Bravo, ClaraRueda, ClaudiaBoada, DavidSánchez Antón, Maria TeresaKacerovsky, MarianJacobsson, BoPalacio, MontsePart prematurLíquid amniòticEmbarassadesPremature laborAmniotic liquidPregnant womenObjectives: To prospectively validate the diagnostic performance of a non-invasive point-of-care tool (Rapid IAI System), including vaginal alpha-fetoprotein and interleukin-6, to predict the occurrence of intra-amniotic inflammation in a Spanish cohort of patients admitted with a diagnosis of preterm labor and intact membranes. Methods: From 2017 to 2022, we prospectively evaluated a cohort of pregnant women diagnosed with preterm labor and intact membranes admitted below 34+0 weeks who underwent amniocentesis to rule-in/out intra-amniotic infection and/or inflammation. Vaginal sampling was performed at the time of amniocentesis or within 24-48 h. Amniotic fluid IL-6, vaginal alpha-fetoprotein and vaginal IL-6 concentrations were measured using a point-of-care tool provided by Hologic Inc., "Rapid IAI System". We defined intra-amniotic inflammation when amniotic fluid IL-6 values were greater than 11.3 ng/mL. During recruitment, clinicians were blinded to the results of the point-of-care tool. The original prediction model proposed by Hologic Inc. to predict intra-amniotic inflammation was validated in this cohort of patients. Results: We included 151 patients diagnosed with preterm labor and intact membranes. Among these, 29 (19.2 %) had intra-amniotic inflammation. The algorithm including vaginal IL-6 and alpha-fetoprotein showed an area under curve to predict intra-amniotic inflammation of 80.3 % (±5.3 %) with a sensitivity of 72.4 %, specificity of 84.6 %, positive predictive valuve (PPV) of 52.5 %, negative predictive value (NPV) of 92.9 %, and a positive likelihood ratio (LR+) of 4.6 and negative likelihood ratio (LR-) of 0.33. Conclusions: External validation of a non-invasive rapid point-of-care tool, including vaginal alpha-fetoprotein and IL-6, showed very good diagnostic performance for predicting the absence of intra-amniotic inflammation in women with preterm labor and intact membranes.Walter de Gruyter2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/219980Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1515/jpm-2024-0178Journal of Perinatal Medicine, 2024, vol. 53, num.2, p. 170-178https://doi.org/10.1515/jpm-2024-0178(c) Walter de Gruyter, 2024info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2199802026-05-27T06:46:51Z
dc.title.none.fl_str_mv External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
title External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
spellingShingle External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
Cobo Cobo, Maria Teresa
Part prematur
Líquid amniòtic
Embarassades
Premature labor
Amniotic liquid
Pregnant women
title_short External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
title_full External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
title_fullStr External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
title_full_unstemmed External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
title_sort External validation of a non-invasive vaginal tool to assess the risk of intra-amniotic inflammation in pregnant women with preterm labor and intact membranes
dc.creator.none.fl_str_mv Cobo Cobo, Maria Teresa
Burgos Artizzu, Xavier P.
Ferrero Martinez, Sílvia
Balcells, Judith
Bosch, Jaime
Gené, Amadeu
Murillo Bravo, Clara
Rueda, Claudia
Boada, David
Sánchez Antón, Maria Teresa
Kacerovsky, Marian
Jacobsson, Bo
Palacio, Montse
author Cobo Cobo, Maria Teresa
author_facet Cobo Cobo, Maria Teresa
Burgos Artizzu, Xavier P.
Ferrero Martinez, Sílvia
Balcells, Judith
Bosch, Jaime
Gené, Amadeu
Murillo Bravo, Clara
Rueda, Claudia
Boada, David
Sánchez Antón, Maria Teresa
Kacerovsky, Marian
Jacobsson, Bo
Palacio, Montse
author_role author
author2 Burgos Artizzu, Xavier P.
Ferrero Martinez, Sílvia
Balcells, Judith
Bosch, Jaime
Gené, Amadeu
Murillo Bravo, Clara
Rueda, Claudia
Boada, David
Sánchez Antón, Maria Teresa
Kacerovsky, Marian
Jacobsson, Bo
Palacio, Montse
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Part prematur
Líquid amniòtic
Embarassades
Premature labor
Amniotic liquid
Pregnant women
topic Part prematur
Líquid amniòtic
Embarassades
Premature labor
Amniotic liquid
Pregnant women
description Objectives: To prospectively validate the diagnostic performance of a non-invasive point-of-care tool (Rapid IAI System), including vaginal alpha-fetoprotein and interleukin-6, to predict the occurrence of intra-amniotic inflammation in a Spanish cohort of patients admitted with a diagnosis of preterm labor and intact membranes. Methods: From 2017 to 2022, we prospectively evaluated a cohort of pregnant women diagnosed with preterm labor and intact membranes admitted below 34+0 weeks who underwent amniocentesis to rule-in/out intra-amniotic infection and/or inflammation. Vaginal sampling was performed at the time of amniocentesis or within 24-48 h. Amniotic fluid IL-6, vaginal alpha-fetoprotein and vaginal IL-6 concentrations were measured using a point-of-care tool provided by Hologic Inc., "Rapid IAI System". We defined intra-amniotic inflammation when amniotic fluid IL-6 values were greater than 11.3 ng/mL. During recruitment, clinicians were blinded to the results of the point-of-care tool. The original prediction model proposed by Hologic Inc. to predict intra-amniotic inflammation was validated in this cohort of patients. Results: We included 151 patients diagnosed with preterm labor and intact membranes. Among these, 29 (19.2 %) had intra-amniotic inflammation. The algorithm including vaginal IL-6 and alpha-fetoprotein showed an area under curve to predict intra-amniotic inflammation of 80.3 % (±5.3 %) with a sensitivity of 72.4 %, specificity of 84.6 %, positive predictive valuve (PPV) of 52.5 %, negative predictive value (NPV) of 92.9 %, and a positive likelihood ratio (LR+) of 4.6 and negative likelihood ratio (LR-) of 0.33. Conclusions: External validation of a non-invasive rapid point-of-care tool, including vaginal alpha-fetoprotein and IL-6, showed very good diagnostic performance for predicting the absence of intra-amniotic inflammation in women with preterm labor and intact membranes.
publishDate 2024
dc.date.none.fl_str_mv 2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/219980
url https://hdl.handle.net/2445/219980
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1515/jpm-2024-0178
Journal of Perinatal Medicine, 2024, vol. 53, num.2, p. 170-178
https://doi.org/10.1515/jpm-2024-0178
dc.rights.none.fl_str_mv (c) Walter de Gruyter, 2024
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) Walter de Gruyter, 2024
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Walter de Gruyter
publisher.none.fl_str_mv Walter de Gruyter
dc.source.none.fl_str_mv Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,81155

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