Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02672891|
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Device: condom balloon catheter||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- control uterine bleeding (normal lochia). [ Time Frame: 30 minutes ]
- Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy) [ Time Frame: 24 hours ]
- Maternal complications (admission to intensive care unit (ICU)) [ Time Frame: 24 hours ]
- Maternal complications (mortality) [ Time Frame: 24 hours ]
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
|Shebin Elkom, Menoufia, Egypt, 11111|
|Principal Investigator:||Hamed El Ellakwa, MD||Menoufiya faculty of medicine,menoufiya university,ministry of higher education|