Trial | NCT02861482  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    472
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.
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.
Study Started
Jan 31
2015
Primary Completion
Mar 31
2016
Study Completion
Mar 31
2016
Last Update
Dec 16
2016
Estimate

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

Bakri Ballon Experimental

All the enrolled patients who would undergo the laying of Bakri Balloon

Criteria 

Inclusion Criteria:

Women with vaginal or cesarean delivery;
PPH caused by: Uterine Atony, Placenta Factors, Coagulation disorders, Hematological disorders, Hepatic diseases, Obstetric DIC;

Not reacting well to continuous uterine massage or uterotonic agents including oxytocin (0.04IU/L ivgtt to a maximum of 60IU), Hemabate (250-500ug im) and Duratocin (100ug iv);

Without other conservative surgical treatment(uterine compression suture, internal arterial embolism; vascular ligation);
Signing the informed consents;

Exclusion Criteria:

Has undergone or will undergo conservative surgical treatment(uterine compression suture, international arterial embolism; artery ligation);
Impaired soft birth canal injury;
Untreated uterine deformity;
Definite indication for uterectomy.
No Results Posted