Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

Not Applicable

Completed

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

• Registration Number: NCT02861482
• Lead Sponsor: Dongyu Wang

Brief 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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 472

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bakri Ballon	Bakri Balloon	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	B-lynch Suture	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Uterine Artery Embolization using sponges	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Cervical cerclage	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Hysterectomy	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Blood Product	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Uterine Massage	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Oxytocin	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Hemabate	All the enrolled patients who would undergo the laying of Bakri Balloon
Bakri Ballon	Duratocin	All the enrolled patients who would undergo the laying of Bakri Balloon

Primary Outcome Measures

Name	Time	Method
Blood loss after Bakri Ballon temponade	from using Bakri Ballon Temponade to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs

Secondary Outcome Measures

Name	Time	Method
Ratio of Bakri Ballon only without other invasive measures in succeeding controlling PPH to the number of cases	From delivery to remove of Bakri Balloon Temponade with the interval ranging from 24hrs to 51hrs

Trial Locations

Locations (1)

Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China