{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T13:54:13Z","timestamp":1791986053866,"version":"4.4.0"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100014369","name":"Organon BioSciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014369","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pregnancy"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To identify predictors of postpartum hemorrhage (PPH) treatment success with the JADA intrauterine vacuum\u2010induced hemorrhage\u2010control device in post\u2010market settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a retrospective cohort study of PPH managed using the JADA system across 16 centers in the United States (NCT04995887). Treatment success was defined as no treatment escalation or PPH recurrence after device placement. Multivariable logistic regression was used to determine significant predictors of PPH treatment success with a stepwise model selection technique. Selection of the best performing model was determined using area under the receiver operating characteristic (AUC) curves, Akaike information criterion (AIC), and data completeness. In exploratory analyses, we assessed differences in treatment success by cause of bleeding and difference in time to device insertion by self\u2010reported race, including an interaction term between race and insertion time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      From October 2020 to March 2022, 800 individuals had PPH managed with the JADA device. Most individuals delivered vaginally (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0530, 66.3%), self\u2010identified as White (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0463, 58.7%), and had a body mass index at delivery \u226535\u00a0kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0322, 40.2%). Cumulative blood loss (CBL) \u22651000\u00a0mL before device insertion occurred in 59.5% of individuals, and 65.9% experienced isolated uterine atony. Overall, the treatment success rate was 89.5%, varying across the top predictors. Device success ranged from 90.0% to 94.3% when CBL was\u00a0&lt;2000\u00a0mL prior to insertion. The best stepwise logistic regression model had an AUC of 76.5% and an AIC of 462.15. The most important predictors of treatment success were CBL at time of device insertion, bleeding cause, delivery mode, and time from placental\u2010delivery\u2010to\u2010insertion (\n                      <jats:italic>p<\/jats:italic>\n                      value range: 0.00001\u20130.05924). Multiple causes of bleeding (atony and non\u2010atony) were associated with lower treatment success compared to isolated atony (81.9%\u00a0vs. 92.6%,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.001), but not with only non\u2010atony bleeding causes (91.3%,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.12). Individuals who identified as White had shorter time to insertion compared to non\u2010White (38.5 vs. 54.0 min,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.01); however, the interaction between race and insertion time was not significant (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.52).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The two most important predictors of treatment success with JADA device were CBL prior to device insertion and the etiology of the bleeding. Understanding these factors may guide PPH treatment algorithms.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pmf2.70222","type":"journal-article","created":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T19:29:33Z","timestamp":1772998173000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Predicting intrauterine vacuum\u2010induced postpartum hemorrhage\u2010control device treatment success"],"prefix":"10.1002","volume":"2","author":[{"given":"Marcela C.","family":"Smid","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology University of Utah Health Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Organon &amp; Co. Jersey City New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3748-7206","authenticated-orcid":false,"given":"Joseph R.","family":"Biggio","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Ochsner Health New Orleans Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8504-6715","authenticated-orcid":false,"given":"Kara M.","family":"Rood","sequence":"additional","affiliation":[{"name":"The Ohio State University\u2010Wexner Medical Center  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyagriv N.","family":"Simhan","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Medical Center\u2010Magee Womens Hospital  Pittsburgh Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia I.","family":"Carney","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Organon &amp; Co. Jersey City New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damien","family":"Croft","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Organon &amp; Co. Jersey City New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Candice","family":"Yong","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Organon &amp; Co. Jersey City New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dena","family":"Goffman","sequence":"additional","affiliation":[{"name":"Columbia University Irving Medical Center &amp; New York Presbyterian Hospital  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the RUBY Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,27]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"WHO Postpartum Haemorrhage (PPH) Summit.2022. Accessed May 3 2025. Available at:https:\/\/www.who.int\/publications\/m\/item\/who\u2010postpartum\u2010haemorrhage\u2010(pph)\u2010summit."},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.semperi.2018.11.001"},{"key":"e_1_2_8_4_1","unstructured":"Centers for Disease Control and Prevention.Severe Maternal Morbidity in the United States. Accessed February 25 2025. Available at:https:\/\/www.cdc.gov\/reproductivehealth\/maternalinfanthealth\/severematernalmorbidity.html."},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000004972"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(17)30638\u20104"},{"key":"e_1_2_8_7_1","unstructured":"Updated WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Haemorrhage. Accessed May 10 2025. Available at:https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/259379\/WHO\u2010RHR\u201017.21\u2010eng.pdf."},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002351"},{"key":"e_1_2_8_9_1","unstructured":"WHO Recommendation on Uterine Balloon Tamponade for the Treatment of Postpartum Haemorrhage.2021. Accessed May 10 2025.https:\/\/pubmed.ncbi.nlm.nih.gov\/33909382\/."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000005366"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajogmf.2022.100739"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2019.11.1287"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.14116"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.3390\/medicina60101604"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000004228"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000003759"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100040\u20101712166"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2018.04.052"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.26460"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e3182691e62"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2005.072975"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0206663"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.14349"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare9030295"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000005770"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1080\/14767058.2025.2451658"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000004138"},{"key":"e_1_2_8_28_1","unstructured":"https:\/\/www.organon.com\/product\/usa\/pi_circulars\/j\/jada\/jada_system_ifu_blue_seal.pdf."},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874\u2010023\u201002004\u20105"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI129197"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.13591"}],"container-title":["Pregnancy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pmf2.70222","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pmf2.70222","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pmf2.70222","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T13:43:07Z","timestamp":1791985387000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1002\/pmf2.70222"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,27]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1002\/pmf2.70222"],"URL":"https:\/\/doi.org\/10.1002\/pmf2.70222","archive":["Portico"],"relation":{},"ISSN":["2997-9684","2997-9684"],"issn-type":[{"value":"2997-9684","type":"print"},{"value":"2997-9684","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,27]]},"assertion":[{"value":"2025-10-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70222"}}