Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. (Record no. 5582)

MARC details
000 -LEADER
fixed length control field 04467nam a22005657a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 201006s20202020 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0029-7844
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1097/AOG.0000000000004138 [doi]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 32909970
245 ## - TITLE STATEMENT
Title Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.
251 ## - Source
Source Obstetrics & Gynecology. 136(5):882-891, 2020 11.
252 ## - Abbreviated Source
Abbreviated source Obstet Gynecol. 136(5):882-891, 2020 11.
252 ## - Abbreviated Source
Former abbreviated source Obstet Gynecol. 2020 Sep 09
253 ## - Journal Name
Journal name Obstetrics and gynecology
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2020
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2021
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2020-10-06
268 ## - Previous citation
-- Obstetrics & Gynecology. 2020 Sep 09
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
520 ## - SUMMARY, ETC.
Abstract CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract FUNDING SOURCE: Alydia Health, Inc.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.
520 ## - SUMMARY, ETC.
Abstract 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%).
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Postpartum Hemorrhage/th [Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Uterine Balloon Tamponade/is [Instrumentation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vacuum Extraction, Obstetrical/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adult
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Blood Transfusion/sn [Statistics & Numerical Data]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Intrauterine Devices
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Postpartum Hemorrhage/et [Etiology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pregnancy
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Prospective Studies
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Washington Hospital Center
656 ## - INDEX TERM--OCCUPATION
Department Obstetrics and Gynecology/Maternal-Fetal Medicine
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Iqbal, Sara N
790 ## - Authors
All authors A Bentum NA, Chien EK, Clark SM, D'Alton ME, Dudley D, Duzyj CM, Gibbins KJ, Gibson KS, Goffman D, Iqbal SN, Kominiarek MA, Paglia MJ, Rood KM, Rosen T, Simhan HN, Skupski DW, Smid MC, Subramaniam A, Tuuli MG, Wine KD
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1097/AOG.0000000000004138">https://dx.doi.org/10.1097/AOG.0000000000004138</a>
Public note https://dx.doi.org/10.1097/AOG.0000000000004138
-- https://dx.doi.org/10.1097/AOG.0000000000004138
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1097/AOG.0000000000004138">https://dx.doi.org/10.1097/AOG.0000000000004138</a>
Public note https://dx.doi.org/10.1097/AOG.0000000000004138
-- https://dx.doi.org/10.1097/AOG.0000000000004138
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
              10/06/2020   32909970 32909970 10/06/2020 10/06/2020 Journal Article