Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage
NCT ID: NCT02672891
Last Updated: 2016-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-05-31
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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Menoufia Obstetrics and Gynecology Group
OTHER
Responsible Party
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Principal Investigators
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Hamed El Ellakwa, MD
Role: PRINCIPAL_INVESTIGATOR
Menoufiya faculty of medicine,menoufiya university,ministry of higher education
Locations
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Menoufia University
Shebin Elkom, Menoufia, Egypt
Countries
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References
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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.
Other Identifiers
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MenoufiaOGG
Identifier Type: -
Identifier Source: org_study_id
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