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

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Citation: Obstetrics & Gynecology. 136(5):882-891, 2020 11.PMID: 32909970Institution: MedStar Washington Hospital CenterDepartment: Obstetrics and Gynecology/Maternal-Fetal MedicineForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Postpartum Hemorrhage/th [Therapy] | *Uterine Balloon Tamponade/is [Instrumentation] | *Vacuum Extraction, Obstetrical/ae [Adverse Effects] | Adult | Blood Transfusion/sn [Statistics & Numerical Data] | Female | Humans | Intrauterine Devices | Postpartum Hemorrhage/et [Etiology] | Pregnancy | Prospective Studies | Treatment OutcomeYear: 2020 Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:

0029-7844

Name of journal: Obstetrics and gynecologyAbstract: CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.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.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.OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.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%).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 KDOriginally published: Obstetrics & Gynecology. 2020 Sep 09Fiscal year: FY2021Digital Object Identifier:

Date added to catalog: 2020-10-06

Holdings ( 1 )
Title notes ( 8 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	32909970	Available		32909970

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.

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.

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.

OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.

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%).

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