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Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage

OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial...

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Autores principales: D’Alton, Mary E., Rood, Kara M., Smid, Marcela C., Simhan, Hyagriv N., Skupski, Daniel W., Subramaniam, Akila, Gibson, Kelly S., Rosen, Todd, Clark, Shannon M., Dudley, Donald, Iqbal, Sara N., Paglia, Michael J., Duzyj, Christina M., Chien, Edward K., Gibbins, Karen J., Wine, Kathryn D., Bentum, Nana Ama A., Kominiarek, Michelle A., Tuuli, Methodius G., Goffman, Dena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7575019/
https://www.ncbi.nlm.nih.gov/pubmed/32909970
http://dx.doi.org/10.1097/AOG.0000000000004138
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author D’Alton, Mary E.
Rood, Kara M.
Smid, Marcela C.
Simhan, Hyagriv N.
Skupski, Daniel W.
Subramaniam, Akila
Gibson, Kelly S.
Rosen, Todd
Clark, Shannon M.
Dudley, Donald
Iqbal, Sara N.
Paglia, Michael J.
Duzyj, Christina M.
Chien, Edward K.
Gibbins, Karen J.
Wine, Kathryn D.
Bentum, Nana Ama A.
Kominiarek, Michelle A.
Tuuli, Methodius G.
Goffman, Dena
author_facet D’Alton, Mary E.
Rood, Kara M.
Smid, Marcela C.
Simhan, Hyagriv N.
Skupski, Daniel W.
Subramaniam, Akila
Gibson, Kelly S.
Rosen, Todd
Clark, Shannon M.
Dudley, Donald
Iqbal, Sara N.
Paglia, Michael J.
Duzyj, Christina M.
Chien, Edward K.
Gibbins, Karen J.
Wine, Kathryn D.
Bentum, Nana Ama A.
Kominiarek, Michelle A.
Tuuli, Methodius G.
Goffman, Dena
author_sort D’Alton, Mary E.
collection PubMed
description OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device. RESULTS: Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88–98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0–5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1–3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION: Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.
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spelling pubmed-75750192020-10-29 Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage D’Alton, Mary E. Rood, Kara M. Smid, Marcela C. Simhan, Hyagriv N. Skupski, Daniel W. Subramaniam, Akila Gibson, Kelly S. Rosen, Todd Clark, Shannon M. Dudley, Donald Iqbal, Sara N. Paglia, Michael J. Duzyj, Christina M. Chien, Edward K. Gibbins, Karen J. Wine, Kathryn D. Bentum, Nana Ama A. Kominiarek, Michelle A. Tuuli, Methodius G. Goffman, Dena Obstet Gynecol Contents OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device. RESULTS: Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88–98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0–5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1–3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION: Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673. Lippincott Williams & Wilkins 2020-11 2020-09-07 /pmc/articles/PMC7575019/ /pubmed/32909970 http://dx.doi.org/10.1097/AOG.0000000000004138 Text en © 2020 The Authors. Published by Wolters Kluwer Health, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Contents
D’Alton, Mary E.
Rood, Kara M.
Smid, Marcela C.
Simhan, Hyagriv N.
Skupski, Daniel W.
Subramaniam, Akila
Gibson, Kelly S.
Rosen, Todd
Clark, Shannon M.
Dudley, Donald
Iqbal, Sara N.
Paglia, Michael J.
Duzyj, Christina M.
Chien, Edward K.
Gibbins, Karen J.
Wine, Kathryn D.
Bentum, Nana Ama A.
Kominiarek, Michelle A.
Tuuli, Methodius G.
Goffman, Dena
Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage
title Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage
title_full Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage
title_fullStr Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage
title_full_unstemmed Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage
title_short Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage
title_sort intrauterine vacuum-induced hemorrhage-control device for rapid treatment of postpartum hemorrhage
topic Contents
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7575019/
https://www.ncbi.nlm.nih.gov/pubmed/32909970
http://dx.doi.org/10.1097/AOG.0000000000004138
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