作者
Mary E D’Alton, Kara M Rood, Marcela C Smid, Hyagriv N Simhan, Daniel W Skupski, Akila Subramaniam, Kelly S Gibson, Todd Rosen, Shannon M Clark, Donald Dudley, Sara N Iqbal, Michael J Paglia, Christina M Duzyj, Edward K Chien, Karen J Gibbins, Kathryn D Wine, Nana Ama A Bentum, Michelle A Kominiarek, Methodius G Tuuli, Dena Goffman
发表日期
2020/11/1
期刊
Obstetrics & Gynecology
卷号
136
期号
5
页码范围
882-891
出版商
LWW
简介
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 …
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ME D'Alton, KM Rood, MC Smid, HN Simhan… - Obstetrics & Gynecology, 2020