drugset / Trial / NCT02861482

Summary

Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic medical disorders (including inherited and acquired coagulopathy). Management of PPH contains the application of uterotonic agents, using hemostasis agents, transfusion of blood component products, conservative procedures (intrauterine packing or balloon tamponade, compression sutures, vascular ligation and uterine artery embolization using sponges), and even hysterectomy. The Bakri Balloon has attained its efficacy and popularity ever since it was invented by Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data of preventive usage. The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early management of PPH.

Timeline

Start
2015-01
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Background Carbetocin Peptide 100 ug
Background Carboprost Tromethamine Unknown 250 ug
Background Carboprost Tromethamine Unknown 500 ug
Background Oxytocin Peptide 20 iu Intravenous
Background Oxytocin Peptide 60 iu Intravenous

Indications

No indication recorded.