NCT02672891

Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Menoufia Obstetrics and Gynecology Group · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DEVICE	condom balloon catheter	The condom balloon catheters were inserted into the uterine cavity digitally or with forceps .Tight vaginal pack was inserted or cervical stitch was done to prevent displacement of the balloon catheter. (2)-Insertion at Cesarean Section: The catheter was inserted through the uterine incision (pushing the tip to the fundus and the drainage port through the cervix into the vagina) or transvaginally and inflated after the uterine incision was closed.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2016-02-03
• Last updated: 2016-02-03

Locations

1 site across 1 country: Egypt