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Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT02672891
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
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 .

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Device: condom balloon catheter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage in a Low Resource Setting
Study Start Date : May 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. control uterine bleeding (normal lochia). [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy) [ Time Frame: 24 hours ]
  2. Maternal complications (admission to intensive care unit (ICU)) [ Time Frame: 24 hours ]
  3. Maternal complications (mortality) [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672891


Locations
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Egypt
Menoufia University
Shebin Elkom, Menoufia, Egypt, 11111
Sponsors and Collaborators
Menoufia Obstetrics and Gynecology Group
Investigators
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Principal Investigator: Hamed El Ellakwa, MD Menoufiya faculty of medicine,menoufiya university,ministry of higher education

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Menoufia Obstetrics and Gynecology Group
ClinicalTrials.gov Identifier: NCT02672891     History of Changes
Other Study ID Numbers: MenoufiaOGG
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes

Keywords provided by Menoufia Obstetrics and Gynecology Group:
Postpartum Hemorrhage
Uterine Tamponade
Condom Catheter

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage