1. Intrauterine double-balloon tamponade vs gauze packing in the management of placenta previa: A multicentre randomized controlled trial
- Author
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Jing Wei, Hongfang Ju, Youdi Xu, Ning Gu, Yali Hu, Yimin Dai, Biyun Xu, and Zhiqun Wang
- Subjects
Adult ,medicine.medical_specialty ,Blood transfusion ,Balloon tamponade ,medicine.medical_treatment ,Placenta Previa ,uterine balloon tamponade ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Pregnancy ,medicine ,Humans ,030212 general & internal medicine ,Hysterectomy ,business.industry ,Cesarean Section ,Postpartum Hemorrhage ,General Medicine ,Clinical Trial/Experimental Study ,medicine.disease ,Intensive care unit ,Surgery ,Placenta previa ,Catheter ,030220 oncology & carcinogenesis ,Hemostasis ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Female ,business ,Research Article - Abstract
Supplemental Digital Content is available in the text, 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
- Published
- 2020