Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672891
• Other study ID #: MenoufiaOGG
• Status: Completed
• Phase: N/A
• First received: December 23, 2015
• Last updated: January 31, 2016
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2016
• Source: Menoufia Obstetrics and Gynecology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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 in?ated after the uterine incision was closed.

Locations

Country	Name	City	State
Egypt	Menoufia University	Shebin Elkom	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia Obstetrics and Gynecology Group

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Schmidt J, Hotz HG, Foitzik T, Ryschich E, Buhr HJ, Warshaw AL, Herfarth C, Klar E. Intravenous contrast medium aggravates the impairment of pancreatic microcirculation in necrotizing pancreatitis in the rat. Ann Surg. 1995 Mar;221(3):257-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	control uterine bleeding (normal lochia).		30 minutes	Yes
Secondary	Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy)		24 hours	Yes
Secondary	Maternal complications (admission to intensive care unit (ICU))		24 hours	Yes
Secondary	Maternal complications (mortality)		24 hours	Yes