An interventional study of condom balloon catheter in Postpartum Hemorrhage, sponsored by Menoufia Obstetrics and Gynecology Group. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by Menoufia Obstetrics and Gynecology Group · Not applicable, Interventional, and Treatment
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 .
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.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's enrollment of 50 is below the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Menoufia Obstetrics and Gynecology Group is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Plan to share: Yes — Yes
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Menoufia Obstetrics and Gynecology Group