Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

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

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 .

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Device: condom balloon catheter

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shebin Elkom, Menoufia, Egypt, 11111
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Device; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
control uterine bleeding (normal lochia).	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Menoufia Obstetrics and Gynecology Group
• Investigators: Principal Investigator: Hamed El Ellakwa, MD, Menoufiya faculty of medicine,menoufiya university,ministry of higher education

Publications and helpful links

General Publications

• 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. doi: 10.1097/00000658-199503000-00007.
• Kandeel M, Sanad Z, Ellakwa H, El Halaby A, Rezk M, Saif I. Management of postpartum hemorrhage with intrauterine balloon tamponade using a condom catheter in an Egyptian setting. Int J Gynaecol Obstet. 2016 Dec;135(3):272-275. doi: 10.1016/j.ijgo.2016.06.018. Epub 2016 Aug 21.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: January 31, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: January 31, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Postpartum Hemorrhage; Uterine Tamponade; Condom Catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: MenoufiaOGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No