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Text
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<a href="http://doi.org/10.1097/aog.0000000000004138" target="_blank" rel="noreferrer noopener">http://doi.org/10.1097/aog.0000000000004138</a>
ISSN
1873-233X 0029-7844
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<a href="http://neomed.idm.oclc.org/login?url=http://doi.org/10.1097/aog.0000000000004138" target="_blank" rel="noreferrer noopener">NEOMED Full-text Holding (if available) - Proxy DOI: 10.1097/aog.0000000000004138</a>
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Update Year & Number
Hospital List
Dublin Core
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Title
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Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.
Publisher
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Obstetrics and Gynecology
Date
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2020
2020-09-09
Creator
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D'Alton ME; Rood KM; Smid MC; Simhan HN; Skupski DW; Subramaniam A; Gibson KS; Rosen T; Clark SM; Dudley D; Iqbal SN; Paglia MJ; Duzyj CM; Chien EK; Gibbins KJ; Wine KD; Bentum NA; Kominiarek MA; Tuuli MG; Goffman D
Description
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OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: ptA 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.
Identifier
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<a href="http://doi.org/10.1097/aog.0000000000004138" target="_blank" rel="noreferrer noopener">10.1097/aog.0000000000004138</a>
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journalArticle
2020
Bentum NA
Chien EK
Clark SM
D'Alton ME
Dudley D
Duzyj CM
Gibbins KJ
Gibson KS
Goffman D
Hospital List
Iqbal SN
journalArticle
Kominiarek MA
Obstetrics and gynecology
Paglia MJ
Rood KM
Rosen T
Simhan HN
Skupski DW
Smid MC
Subramaniam A
Tuuli MG
Wine KD