Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

NCT02861482 | Completed DMC

• 1 other identifier: 2015COOK
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Keywords

PPH, Bakri Ballon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Bakri Ballon

EXPERIMENTAL

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

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

Interventions

Bakri Balloon DEVICE

Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped

Bakri Ballon

Oxytocin DRUG

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

Bakri Ballon

Hemabate DRUG

using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon

Bakri Ballon

Duratocin DRUG

using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon

Bakri Ballon

Uterine Massage PROCEDURE

continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon

Bakri Ballon

B-lynch Suture PROCEDURE

One of conservative surgical procedures if Bakri Balloon didn't work

Bakri Ballon

Uterine Artery Embolization using sponges PROCEDURE

One of conservative surgical procedures if Bakri Balloon didn't work

Bakri Ballon

Cervical cerclage PROCEDURE

One of conservative surgical procedures if Bakri Balloon didn't work

Bakri Ballon

Hysterectomy PROCEDURE

Hysterectomy with all the above measures not working

Bakri Ballon

Blood Product DRUG

transfusion of blood product if necessary no matter which surgical procedure has been taken

Bakri Ballon

Eligibility Criteria

• Age: 19 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongyu Wang: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• The Third Affiliated Hospital of Guangzhou Medical University: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Huadu District People's Hospital of Guangzhou: collaborator
• Shenzhen Maternity & Child Healthcare Hospital: collaborator
• Dongguan Maternity & Child Health Hospital: collaborator
• Zhuhai Maternity & Child Healthcare Hospital: collaborator
• The First Maternity & Child Healthcare Hospital of Huizhou: collaborator
• Nanhai Women's and Children's Hospital: collaborator
• Jiangmen Maternity & Child Health Care Hospital: collaborator
• The Third Affiliated Hospital of Southern Medical University: collaborator
• Southern Medical University, China: collaborator
• Zhongshan Dongsheng hospital: collaborator
• Xiaolan People's Hospital of Zhongshan: collaborator
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: collaborator
• Baoan District People's Hospital of Shenzhen: collaborator
• Zengcheng District People's Hospital of Guangzhou: collaborator

Study Sites (1)

Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; carboprost tromethamine; Cerclage, Cervical; Hysterectomy

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Obstetric Surgical Procedures; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Zilian Wang, M.D.,PhD

  Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: August 10, 2016
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)