Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Device: condom balloon catheter

• Registration Number: NCT02672891
• Lead Sponsor: Menoufia Obstetrics and Gynecology Group

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 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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2015-12-23
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-31
• Last Update Submitted: 2016-01-31
• Study First Posted: 2016-02-03
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• women with primary postpartum hemorrhage ( defined as >500 ml estimated blood loss after vaginal delivery or >1000 ml after cesarean delivery)in the first 24 h , unresponsive to uterotonics and bimanual compression were enrolled

Exclusion Criteria

• Patients with traumatic PPH, retained placenta, coagulopathy and severe systemic diseases were excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device	condom balloon catheter	condom balloon catheter which is composed of a latex condom (SURE natural latex condom, Shanghai) and a 16-20 F, 2 ways silicon coated Foley catheter (Egypt). The catheter was introduced inside the condom and tied over tightly several times with a silk suture, to prevent air escape.

Primary Outcome Measures

Name	Time	Method
control uterine bleeding (normal lochia).	30 minutes

Secondary Outcome Measures

Name	Time	Method
Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy)	24 hours
Maternal complications (admission to intensive care unit (ICU))	24 hours
Maternal complications (mortality)	24 hours

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shebin Elkom, Menoufia, Egypt