A uterine suction device to prevent postpartum hemorrhage in scheduled cesarean delivery: A pilot study

Objective: Postpartum hemorrhage (PPH) remains a leading cause of maternal morbidity and mortality, with cesarean delivery posing a heightened risk. While interventions such as prophylactic tranexamic acid and balloon tamponade have limitations—especially when the cervix is not dilated—vacuum-assisted uterine tamponade may offer a novel intraoperative approach. This prospective pilot study evaluated the feasibility of the Daisy™ catheter, a cervical drain device developed by Raydiant Oximetry, Inc., designed to evacuate blood and promote uterine contraction through continuous negative-pressure suction. Study Design We enrolled ten pregnant individuals scheduled for cesarean delivery at a tertiary care center, all of whom had at least one PPH risk factor. Following fetal and placental delivery, the Daisy™ catheter was inserted trans-hysterotomically, advanced through the cervix, and connected to wall suction (–90 to –100 mm Hg) for two hours. Quantitative blood loss (QBL), perioperative hemoglobin change, ultrasound findings, and adverse events were recorded. Results Device placement succeeded in 9 of 10 cases; one failure was due to an undiagnosed cervical cerclage. Eight participants completed the full suction protocol. Mean hemoglobin decline from preoperative baseline to postoperative day 1 was 1.36 ± 0.47 g/dL, significantly lower than the 1.9 ± 1.1 g/dL observed in a historical cohort from 31 U.S. hospitals (P = 0.019). Ultrasound at two hours postpartum confirmed correct device placement, absence of intrauterine clot, and no evidence of trauma. Device removal was uncomplicated, and no adverse events were reported. Conclusion These preliminary findings suggest that intraoperative use of the Daisy™ device is feasible, well-tolerated, and may reduce blood loss after cesarean delivery. Larger, randomized trials are warranted to evaluate its impact on transfusion rates, reoperation, and overall maternal outcomes, particularly in settings where alternative tamponade methods are limited.

Publikationsverlauf

Eingereicht: 09. Oktober 2025

Angenommen nach Revision: 20. November 2025

Accepted Manuscript online:
24. November 2025