Determination of Blood Loss After CS
Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section
1 other identifier
interventional
130
0 countries
N/A
Brief Summary
Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Sep 2020
Shorter than P25 for early_phase_1
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, 2020
CompletedFirst Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedSeptember 16, 2020
September 1, 2020
1 year
September 9, 2020
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
amount of blood loss
comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
baseline
Secondary Outcomes (1)
maternal and neonatal complication
baseline
Study Arms (2)
group A
ACTIVE COMPARATORwill receive oxytocin
group B
ACTIVE COMPARATORwill receive tranexamic acid plus oxytocin
Interventions
comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
Eligibility Criteria
You may qualify if:
- Age : 20-40 year
- Gestational age is between 37-41weeks
- Delivery by uncomplicated elective CS
You may not qualify if:
- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- women will be given serial number ,randomization will be done through a computer generated system
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- egypt
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 16, 2020
Study Start
September 1, 2020
Primary Completion
September 1, 2021
Study Completion
October 1, 2021
Last Updated
September 16, 2020
Record last verified: 2020-09