{"id":"https://openalex.org/W4413005671","doi":"https://doi.org/10.1016/j.ajog.2025.07.050","title":"Phase 3 clinical trial on the prevention of maternal-fetal cytomegalovirus transmission with specific hyperimmunoglobulin could not demonstrate efficacy","display_name":"Phase 3 clinical trial on the prevention of maternal-fetal cytomegalovirus transmission with specific hyperimmunoglobulin could not demonstrate efficacy","publication_year":2025,"publication_date":"2025-08-05","ids":{"openalex":"https://openalex.org/W4413005671","doi":"https://doi.org/10.1016/j.ajog.2025.07.050","pmid":"https://pubmed.ncbi.nlm.nih.gov/40759386"},"language":"en","primary_location":{"id":"doi:10.1016/j.ajog.2025.07.050","doi":"https://doi.org/10.1016/j.ajog.2025.07.050","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.ajog.2025.07.050","pdf_url":"https://www.ajog.org/article/S0002-9378(25)00531-9/pdf","source":{"id":"https://openalex.org/S122347013","display_name":"American Journal of Obstetrics and Gynecology","issn_l":"0002-9378","issn":["0002-9378","1085-8709","1097-6868"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Obstetrics and Gynecology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://www.ajog.org/article/S0002-9378(25)00531-9/pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5054104985","display_name":"Karl Oliver Kagan","orcid":"https://orcid.org/0000-0003-1497-5143","observed_orcids":["https://orcid.org/0000-0003-1497-5143"]},"institutions":[{"id":"https://openalex.org/I4210094118","display_name":"Universit\u00e4tsklinikum T\u00fcbingen","ror":"https://ror.org/00pjgxh97","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210094118"]},{"id":"https://openalex.org/I4210122374","display_name":"Universit\u00e4ts Frauenklinik","ror":"https://ror.org/02veq1j93","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210094118","https://openalex.org/I4210122374"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Karl Oliver Kagan","raw_affiliation_strings":["Department f\u00fcr Frauengesundheit, Universit\u00e4tsklinikum, T\u00fcbingen, Germany","Universit\u00e4tsklinikum, Department f\u00fcr Frauengesundheit, Calwerstrasse 7, 72076 T\u00fcbingen, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department f\u00fcr Frauengesundheit, Universit\u00e4tsklinikum, T\u00fcbingen, Germany","institution_ids":["https://openalex.org/I4210094118","https://openalex.org/I4210122374"]},{"raw_affiliation_string":"Universit\u00e4tsklinikum, Department f\u00fcr Frauengesundheit, Calwerstrasse 7, 72076 T\u00fcbingen, Germany","institution_ids":["https://openalex.org/I4210094118","https://openalex.org/I4210122374"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5020055917","display_name":"Martin Enders","orcid":"https://orcid.org/0000-0003-3218-074X","observed_orcids":["https://orcid.org/0000-0003-3218-074X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Martin Enders","raw_affiliation_strings":["Labor Prof. G. Enders & Kollegen, Medizinische Diagnostik, Stuttgart, Germany","Labor Prof. G. Enders & Kollegen, Medizinische Diagnostik, Rosenbergstrasse 85, 70193 Stuttgart, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Labor Prof. G. Enders & Kollegen, Medizinische Diagnostik, Stuttgart, Germany","institution_ids":[]},{"raw_affiliation_string":"Labor Prof. G. Enders & Kollegen, Medizinische Diagnostik, Rosenbergstrasse 85, 70193 Stuttgart, Germany","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5016586425","display_name":"Silke Aigner","orcid":"https://orcid.org/0009-0003-1285-1662","observed_orcids":["https://orcid.org/0009-0003-1285-1662"]},"institutions":[{"id":"https://openalex.org/I4210107112","display_name":"Biotest (Germany)","ror":"https://ror.org/0100f3q33","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210107112"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Silke Aigner","raw_affiliation_strings":["Biotest AG, Dreieich, Germany","Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biotest AG, Dreieich, Germany","institution_ids":["https://openalex.org/I4210107112"]},{"raw_affiliation_string":"Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany","institution_ids":["https://openalex.org/I4210107112"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5081173472","display_name":"Joachim Sch\u00fctze","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210107112","display_name":"Biotest (Germany)","ror":"https://ror.org/0100f3q33","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210107112"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Joachim Sch\u00fctze","raw_affiliation_strings":["Biotest AG, Dreieich, Germany","Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biotest AG, Dreieich, Germany","institution_ids":["https://openalex.org/I4210107112"]},{"raw_affiliation_string":"Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany","institution_ids":["https://openalex.org/I4210107112"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5059929801","display_name":"Stephan Lentze","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210107112","display_name":"Biotest (Germany)","ror":"https://ror.org/0100f3q33","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210107112"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Stephan Lentze","raw_affiliation_strings":["Biotest AG, Dreieich, Germany","Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biotest AG, Dreieich, Germany","institution_ids":["https://openalex.org/I4210107112"]},{"raw_affiliation_string":"Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany","institution_ids":["https://openalex.org/I4210107112"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5051303107","display_name":"Christiane Staiger","orcid":"https://orcid.org/0000-0001-8687-7687","observed_orcids":["https://orcid.org/0000-0001-8687-7687"]},"institutions":[{"id":"https://openalex.org/I4210107112","display_name":"Biotest (Germany)","ror":"https://ror.org/0100f3q33","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210107112"]}],"countries":["DE"],"is_corresponding":true,"raw_author_name":"Christiane Staiger","raw_affiliation_strings":["Biotest AG, Dreieich, Germany. Electronic address: christiane.staiger@biotest.com","Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany. Electronic address: christiane.staiger@biotest.com"],"raw_orcid":"https://orcid.org/0000-0001-8687-7687","affiliations":[{"raw_affiliation_string":"Biotest AG, Dreieich, Germany. Electronic address: christiane.staiger@biotest.com","institution_ids":["https://openalex.org/I4210107112"]},{"raw_affiliation_string":"Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany. Electronic address: christiane.staiger@biotest.com","institution_ids":["https://openalex.org/I4210107112"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5051303107"],"corresponding_institution_ids":["https://openalex.org/I4210107112"],"apc_list":{"value":5410,"currency":"USD","value_usd":5410},"apc_paid":{"value":5410,"currency":"USD","value_usd":5410},"fwci":1.093,"has_fulltext":true,"cited_by_count":2,"citation_normalized_percentile":{"value":0.72106229,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":95,"max":96},"biblio":{"volume":"233","issue":"6","first_page":"e255","last_page":"e256"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10981","display_name":"Cytomegalovirus and herpesvirus research","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10981","display_name":"Cytomegalovirus and herpesvirus research","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10625","display_name":"Herpesvirus Infections and Treatments","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11961","display_name":"Neonatal and Maternal Infections","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/cytomegalovirus","display_name":"cytomegalovirus","score":0.9739999771118164},{"id":"https://openalex.org/keywords/mother-to-child-transmission","display_name":"mother-to-child transmission","score":0.9340000152587891},{"id":"https://openalex.org/keywords/passive-immunization","display_name":"passive immunization","score":0.8109999895095825},{"id":"https://openalex.org/keywords/prevention","display_name":"prevention","score":0.4099999964237213},{"id":"https://openalex.org/keywords/congenital-cytomegalovirus-infection","display_name":"congenital cytomegalovirus infection","score":0.7799999713897705}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9488918781280518},{"id":"https://openalex.org/C2777732132","wikidata":"https://www.wikidata.org/wiki/Q6946","display_name":"Cytomegalovirus","level":5,"score":0.7117790579795837},{"id":"https://openalex.org/C131872663","wikidata":"https://www.wikidata.org/wiki/Q5284418","display_name":"Obstetrics","level":1,"score":0.5626097917556763},{"id":"https://openalex.org/C172680121","wikidata":"https://www.wikidata.org/wiki/Q26513","display_name":"Fetus","level":3,"score":0.520012617111206},{"id":"https://openalex.org/C2910866203","wikidata":"https://www.wikidata.org/wiki/Q6946","display_name":"Cytomegalovirus infections","level":4,"score":0.5100308060646057},{"id":"https://openalex.org/C761482","wikidata":"https://www.wikidata.org/wiki/Q118093","display_name":"Transmission (telecommunications)","level":2,"score":0.4945501983165741},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4884885549545288},{"id":"https://openalex.org/C2779234561","wikidata":"https://www.wikidata.org/wiki/Q11995","display_name":"Pregnancy","level":2,"score":0.426705539226532},{"id":"https://openalex.org/C3019738921","wikidata":"https://www.wikidata.org/wiki/Q4293116","display_name":"Cytomegalovirus infection","level":4,"score":0.4117295742034912},{"id":"https://openalex.org/C159047783","wikidata":"https://www.wikidata.org/wiki/Q7215","display_name":"Virology","level":1,"score":0.25635045766830444},{"id":"https://openalex.org/C2779820661","wikidata":"https://www.wikidata.org/wiki/Q6929","display_name":"Human cytomegalovirus","level":3,"score":0.15753689408302307},{"id":"https://openalex.org/C2776409557","wikidata":"https://www.wikidata.org/wiki/Q149348","display_name":"Herpesviridae","level":4,"score":0.14033758640289307},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.13685771822929382},{"id":"https://openalex.org/C2780727368","wikidata":"https://www.wikidata.org/wiki/Q1928978","display_name":"Viral disease","level":3,"score":0.1292479932308197},{"id":"https://openalex.org/C2522874641","wikidata":"https://www.wikidata.org/wiki/Q808","display_name":"Virus","level":2,"score":0.07422426342964172},{"id":"https://openalex.org/C119599485","wikidata":"https://www.wikidata.org/wiki/Q43035","display_name":"Electrical engineering","level":1,"score":0.0},{"id":"https://openalex.org/C54355233","wikidata":"https://www.wikidata.org/wiki/Q7162","display_name":"Genetics","level":1,"score":0.0},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.0},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1016/j.ajog.2025.07.050","doi":"https://doi.org/10.1016/j.ajog.2025.07.050","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.ajog.2025.07.050","pdf_url":"https://www.ajog.org/article/S0002-9378(25)00531-9/pdf","source":{"id":"https://openalex.org/S122347013","display_name":"American Journal of Obstetrics and Gynecology","issn_l":"0002-9378","issn":["0002-9378","1085-8709","1097-6868"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Obstetrics and Gynecology","raw_type":"journal-article"},{"id":"pmid:40759386","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/40759386","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American journal of obstetrics and gynecology","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1016/j.ajog.2025.07.050","doi":"https://doi.org/10.1016/j.ajog.2025.07.050","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.ajog.2025.07.050","pdf_url":"https://www.ajog.org/article/S0002-9378(25)00531-9/pdf","source":{"id":"https://openalex.org/S122347013","display_name":"American Journal of Obstetrics and Gynecology","issn_l":"0002-9378","issn":["0002-9378","1085-8709","1097-6868"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Obstetrics and Gynecology","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4413005671.pdf","grobid_xml":"https://content.openalex.org/works/W4413005671.grobid-xml"},"referenced_works_count":2,"referenced_works":["https://openalex.org/W3027100209","https://openalex.org/W3122252863"],"related_works":["https://openalex.org/W7119531822","https://openalex.org/W2128497830","https://openalex.org/W7217591908","https://openalex.org/W3201141066","https://openalex.org/W2810318280","https://openalex.org/W2162778062","https://openalex.org/W2108334681","https://openalex.org/W3097416956","https://openalex.org/W4401253418","https://openalex.org/W2032554581"],"abstract_inverted_index":{"Primary":[0],"cytomegalovirus":[1],"(CMV)":[2],"infection":[3],"in":[4],"pregnancy,":[5],"followed":[6],"by":[7],"a":[8,12,46,51],"maternal-fetal":[9,52],"transmission":[10,53],"is":[11],"major":[13],"cause":[14],"of":[15,18,23,40,55,59,69,75],"developmental":[16],"disorders":[17],"newborns":[19],"worldwide.":[20],"The":[21],"efficacy":[22],"passive":[24],"immunization":[25],"with":[26],"specific":[27],"hyperimmunoglobulin":[28],"(CMVIG)":[29],"remains":[30],"equivocal.":[31],"In":[32,45],"previous":[33,47],"studies,":[34],"the":[35],"dosage,":[36],"timing,":[37],"and":[38],"frequency":[39],"CMVIG":[41,76],"administration":[42],"differed":[43],"considerably.":[44],"publication,":[48],"we":[49],"documented":[50],"rate":[54],"6.5%":[56],"(10":[57],"out":[58],"153":[60],"cases":[61],"[95%":[62],"confidence":[63],"interval":[64],"3.2\u201311.7])":[65],"for":[66],"an":[67],"application":[68],"200":[70],"U/kg":[71],"body":[72],"weight":[73],"(BW)":[74],"every":[77],"2":[78],"weeks.":[79]},"counts_by_year":[{"year":2026,"cited_by_count":2}],"updated_date":"2026-11-08T12:12:28.789561","created_date":"2025-10-10T00:00:00"}