NCT02861482

Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

Early Usage of Bakri Postpartum Ballon is More Effective for the Management of Postpartum Hemorrhage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: Dongyu Wang · Academic / Other
• Sex: Female
• Age: 19 Years – 47 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Data of 472 patients from 20 different hospitals had a Bakri balloon tamponade. Enrolled patients would follow the next process: assessment of blood loss intrapartum and 2 hours postpartum; laying the Bakri Balloon; assessment of blood loss, uterine contraction and complications after Bakri Balloon tamponade; further conservative surgical measures (uterine placation (B-lynch suture), arterial embolization; artery ligation; cervical cerclage) or even hysterectomy if necessary; recording the puerperium infection and involution of uterus. Data were analyzed by SPSS 20.0 database. The results were expressed as mean ± standard deviations or median with interquartile range. Differences between groups were assessed by Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate. Correlation analysis was performed using the Spearman rank correlation method. To identify independent relationships and adjust the effects of covariates, multiple linear regression analyses were performed. P values of \<0.05 were considered significant.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DEVICE	Bakri Balloon	Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped
DRUG	Oxytocin	using oxytocin(usage:20IU oxytocin in 500ml lactated Ringer's, ivgtt to a maximum of 60IU) for the first step when dealing with PPH before laying Bakri Balloon
DRUG	Hemabate	using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon
DRUG	Duratocin	using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon
PROCEDURE	Uterine Massage	continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon
PROCEDURE	B-lynch Suture	One of conservative surgical procedures if Bakri Balloon didn't work
PROCEDURE	Uterine Artery Embolization using sponges	One of conservative surgical procedures if Bakri Balloon didn't work
PROCEDURE	Cervical cerclage	One of conservative surgical procedures if Bakri Balloon didn't work
PROCEDURE	Hysterectomy	Hysterectomy with all the above measures not working
DRUG	Blood Product	transfusion of blood product if necessary no matter which surgical procedure has been taken

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-08-10
• Last updated: 2016-12-16

Locations

1 site across 1 country: China