Back to resultsCombined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section
Primary Purpose
Placenta Previa
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bakri balloon
Bilateral Uterine Artery Ligation
Sponsored by
About this trial
This is an interventional prevention trial for Placenta Previa
Eligibility Criteria
Inclusion Criteria:
- women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Exclusion Criteria:
- patients with the high possibility of morbid adherent placenta
- those presented with severe antepartum hemorrhage
- Patients with cardiac, hepatic, renal, or thromboembolic disease;
- patient refuses to consent
Sites / Locations
- Aswan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon
patients with placenta previa undergoing cesarean section underwent insertion of Bakri balloon
Outcomes
Primary Outcome Measures
mean Blood loss after placental separation
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
Secondary Outcome Measures
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
Number of Participants with postpartum hemorrhage
number pf participants with blood loss > 1000ml
Full Information
NCT ID
NCT04518150
First Posted
August 15, 2020
Last Updated
September 18, 2020
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04518150
Brief Title
Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section
Official Title
Clinical Outcomes of Combined Bilateral Uterine Artery Ligation and Bakri Balloon Tamponade During Cesarean Section in Patients With Placenta Previa: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa
Detailed Description
Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Controlled Trial
Masking
Participant
Masking Description
single blind randomized controlled trial
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon
Arm Title
control group
Arm Type
Active Comparator
Arm Description
patients with placenta previa undergoing cesarean section underwent insertion of Bakri balloon
Intervention Type
Device
Intervention Name(s)
Bakri balloon
Other Intervention Name(s)
BBT
Intervention Description
the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally
Intervention Type
Procedure
Intervention Name(s)
Bilateral Uterine Artery Ligation
Other Intervention Name(s)
BUAL
Intervention Description
The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.
Primary Outcome Measure Information:
Title
mean Blood loss after placental separation
Description
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
The number of participant needed for blood transfusion
Description
Calculation of the number of participant needed for blood transfusion
Time Frame
24 hours
Title
Number of Participants with postpartum hemorrhage
Description
number pf participants with blood loss > 1000ml
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Exclusion Criteria:
patients with the high possibility of morbid adherent placenta
those presented with severe antepartum hemorrhage
Patients with cardiac, hepatic, renal, or thromboembolic disease;
patient refuses to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f Sallam, md
Phone
+20102435461
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w Shady, md
Phone
+201022336052
Ext
002
Email
hanygyne@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nahla w Shady, md
Organizational Affiliation
Aswan universirty
Official's Role
Study Chair
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany F Sallam, MD
Phone
0122336052
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name & Degree
Nahla W Shady, MD
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section
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