Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

Dongyu Wang

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Drug: Oxytocin; Procedure: Uterine Artery Embolization using sponges; Drug: Hemabate; Device: Bakri Balloon; Procedure: B-lynch Suture; Procedure: Uterine Massage; Procedure: Cervical cerclage; Drug: Duratocin; Procedure: Hysterectomy; Drug: Blood Product

Study type: Interventional

Funder types: Other

Identifiers

NCT02861482

2015COOK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 472 patients

Sex: Female

Ages: 19 to 47 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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472 participants in 1 patient group

Bakri Ballon

Experimental group

Description:

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

Treatment:

Procedure: Cervical cerclage

Procedure: Uterine Massage

Drug: Duratocin

Drug: Blood Product

Procedure: Hysterectomy

Drug: Oxytocin

Procedure: Uterine Artery Embolization using sponges

Procedure: B-lynch Suture

Drug: Hemabate

Device: Bakri Balloon