Abstract
BACKGROUND: To evaluate the effectiveness and safety of a newly designed intrauterine double-balloon catheter to arrest postpartum hemorrhage (PPH) following cesarean delivery (CD) for placenta previa. METHODS: We conducted an open-label, multicenter randomized controlled trial in two referral centers and one general hospital. Women with continuous bleeding after placental delivery following CD for placenta previa, who failed to respond to uterotonics, suturing and uterine devascularization, and in the absence of suspected deeply invasive accreta were eligible subjects. Eligible subjects were randomized to receive intrauterine double-balloon catheter (n = 102) or gauze packing (n = 102). The main outcome was the rate of successful hemostasis without the need for additional surgical interventions. The secondary outcomes included the volume of blood loss during and after CD, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, surgical complications, intensive care unit admission, need for re-laparotomy, length of hospital stay, and readmission. RESULTS: The 224 participants were recruited before delivery, with 20 excluded (14 cases bleeding stopped after uterotonics and/or local myometrium sutures and 6 patients with placental increta). Finally, 102 women were assigned in catheter group and 102 others in gauze group. There was no difference in the rate of successful hemostasis in the catheter and gauze groups (93.1% vs 91.2%, P = .80). Compared with those in the gauze group, women in the catheter group showed significantly less blood loss within 24 hours postpartum (895 [612.3-1297.8] vs 1156 [882.5-1453.3] ml, P < .01), lower rate of PPH ≥1000 ml (42.2% vs 63.7%, P < .01). Accordingly, women in the catheter group had significantly less maternal adverse events such as postpartum anemia, puerperal morbidity, and postpartum pain. CONCLUSION: Uterine tamponade using a double-balloon catheter was as effective as gauze packing in hemostasis, and appeared to be superior in reducing postpartum blood loss and pain following CD for placenta previa. Using double-balloon catheter in managing PPH in this situation may be a preferable alternative to minimize maternal morbidity.