Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
1 other identifier
interventional
200
1 country
1
Brief Summary
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 24, 2014
CompletedFirst Posted
Study publicly available on registry
October 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 4, 2014
November 1, 2014
6 months
October 24, 2014
November 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of blood loss during cesarean section after placental delivery till end of the operation.
during and 2hours post cesarean section
Secondary Outcomes (3)
1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
up to 24hours postoperative
Adverse affect of tranexamic acid on mother and neonate .
first 24 hours
24 hours post operative haemoglobin and haematocrit .
after 24 hours.
Study Arms (2)
group A
ACTIVE COMPARATORreceiving tranexamic acid
group B
NO INTERVENTIONdoes not receive tranexamic acid
Interventions
Eligibility Criteria
You may qualify if:
- \- Women undergoing caesarean delivery for various elective indications.
- Full term primiparas / multiparas.
- Singleton pregnancy being delivered by LSCS.
You may not qualify if:
- \- Medical problems involving the heart, liver, kidney and brain .
- Blood disorders.
- Allergy to tranexamic acid.
- History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
- Multiple pregnancy, macrosomia.
- Polyhydromnios .
- Patients requiring blood transfusion due to anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams Maternity Hospital
Cairo, 02, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amr Abdelaziz, M.D
Ain Shams Maternity Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial.
Study Record Dates
First Submitted
October 24, 2014
First Posted
October 30, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
September 1, 2015
Last Updated
November 4, 2014
Record last verified: 2014-11