Clinical trial NCT02672891: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Postpartum Hemorrhage
Uterine Tamponade
Condom Catheter
Lead sponsor: Menoufia Obstetrics and Gynecology Group
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: control uterine bleeding (normal lochia).
timeFrame: 30 minutes
Secondary outcomes:
measure: Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy)
timeFrame: 24 hours
measure: Maternal complications (admission to intensive care unit (ICU))
timeFrame: 24 hours
measure: Maternal complications (mortality)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Shebin Elkom
country: Egypt
facility: Menoufia University
state: Menoufia
Study officials:
affiliation: Menoufiya faculty of medicine,menoufiya university,ministry of higher education
name: Hamed El Ellakwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.