- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518163
Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aswan, Egypt, 81528
- Recruiting
- Aswan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
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
|
Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision
Other Names:
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
Other Names:
|
Active Comparator: control group
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
|
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
Other Names:
Intravenous 110 ml saline by slow infusion before skin incision
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean Blood loss after placental separation
Time Frame: 30 minutes
|
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with postpartum hemorrhage
Time Frame: 12 hours
|
number pf participants with blood loss > 1000ml
|
12 hours
|
The number of participant needed of extra surgical maneuvers
Time Frame: 30minutes
|
Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation
|
30minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aswu/279/7/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Minia Maternity University HospitalCompletedPlacenta Previa Without HemorrhageEgypt
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Clinical Trials on Tranexamic Acid
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London School of Hygiene and Tropical MedicineCompleted
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Assiut UniversityCompleted
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Thammasat UniversityCompleted
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Ferring PharmaceuticalsCompleted
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Ain Shams UniversityCompleted
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London School of Hygiene and Tropical MedicineRawalpindi Medical CollegeCompletedPregnancy, High RiskPakistan, Zambia