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Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Primary Purpose

Placenta Previa

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid
placebo to TA
Bakri Balloon
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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;
  • hypersensitivity or contraindications of use of tranexamic acid
  • 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

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 plus 1gm tranexamic acid by intravenous infusion

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 plus saline by intravenous infusion

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

Number of Participants with postpartum hemorrhage
number pf participants with blood loss > 1000ml
The number of participant needed of extra surgical maneuvers
Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation

Full Information

First Posted
August 15, 2020
Last Updated
September 18, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04518163
Brief Title
Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
Official Title
Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind 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
June 30, 2022 (Anticipated)
Study Completion Date
July 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
Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade
Detailed Description
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate. Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.

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
Double blind randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind randomized controlled trial
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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 plus 1gm tranexamic acid by intravenous infusion
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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 plus saline by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TA
Intervention Description
Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision
Intervention Type
Drug
Intervention Name(s)
placebo to TA
Other Intervention Name(s)
saline
Intervention Description
Intravenous 110 ml saline by slow infusion before skin incision
Intervention Type
Device
Intervention Name(s)
Bakri Balloon
Other Intervention Name(s)
BBT
Intervention Description
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
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
Number of Participants with postpartum hemorrhage
Description
number pf participants with blood loss > 1000ml
Time Frame
12 hours
Title
The number of participant needed of extra surgical maneuvers
Description
Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation
Time Frame
30minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women undergoing elective cesarean delivery for complete placenta previa
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; hypersensitivity or contraindications of use of tranexamic acid 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

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Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

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