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 2 hours. Quantitative blood loss, 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 2 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. The ClinicalTrials.gov identifier is NCT06219538.

KEY POINTS: · Vacuum tamponade used during cesarean delivery.. · Daisy device showed safe, feasible deployment.. · Hemoglobin drop was lower than the historical average..