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Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
condom balloon catheter
Sponsored by
Menoufia Obstetrics and Gynecology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Postpartum Hemorrhage, Uterine Tamponade, Condom Catheter

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Menoufia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

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.

Outcomes

Primary Outcome Measures

control uterine bleeding (normal lochia).

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2015
Last Updated
January 31, 2016
Sponsor
Menoufia Obstetrics and Gynecology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02672891
Brief Title
Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage
Official Title
Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage in a Low Resource Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menoufia Obstetrics and Gynecology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Postpartum Hemorrhage, Uterine Tamponade, Condom Catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
condom balloon catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
control uterine bleeding (normal lochia).
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy)
Time Frame
24 hours
Title
Maternal complications (admission to intensive care unit (ICU))
Time Frame
24 hours
Title
Maternal complications (mortality)
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamed El Ellakwa, MD
Organizational Affiliation
Menoufiya faculty of medicine,menoufiya university,ministry of higher education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menoufia University
City
Shebin Elkom
State/Province
Menoufia
ZIP/Postal Code
11111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes
Citations:
PubMed Identifier
7717779
Citation
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.
Results Reference
result
PubMed Identifier
27599602
Citation
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.
Results Reference
derived

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Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

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