Clinical Trial: Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage in a Low Resource Setting

Brief Summary: Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for the management of postpartum hemorrhage involve a stepwise approach including the exclusion of retained products and genital tract trauma. Uterine atony, which is the most common cause, is dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced to arrest the bleeding is the uterine tamponade using various balloons and catheters. The condom catheter uses a sterile rubber catheter fitted with a condom for uterine tamponade .

Detailed Summary:

Objectives: To evaluate the outcome of uterine balloon tamponade using condom-catheter in the management of primary postpartum hemorrhage (PPH).

Material and Methods: Prospective observational study included 50 women with primary postpartum hemorrhage unresponsive to uterotonics and bimanual compression, was conducted at the department of Obstetrics &Gynecology, Menoufia University Hospital, Egypt. Clinical assessment, laboratory investigations and intrauterine condom catheter were applied to all patients. The primary outcome was the success of the balloon to stop bleeding, maternal complications were assessed as secondary outcomes.


Sponsor: Menoufia Obstetrics and Gynecology Group

Current Primary Outcome: control uterine bleeding (normal lochia). [ Time Frame: 30 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy) [ Time Frame: 24 hours ]
  • Maternal complications (admission to intensive care unit (ICU)) [ Time Frame: 24 hours ]
  • Maternal complications (mortality) [ Time Frame: 24 hours ]


Original Secondary Outcome: Same as current

Information By: Menoufia Obstetrics and Gynecology Group

Dates:
Date Received: December 23, 2015
Date Started: May 2011
Date Completion:
Last Updated: January 31, 2016
Last Verified: January 2016