Determination of Blood Loss After CS

Early Phase 1

• Conditions: Effect of Drug
• Interventions: Drug: Tranexamic acid; Drug: Oxytocin

• Registration Number: NCT04549012
• Lead Sponsor: Ain Shams University

Brief Summary

Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS

Detailed Description

tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-14
• Last Update Submitted: 2020-09-14
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

1. Age : 20-40 year

   • 2- Gestational age is between 37-41weeks

3- Delivery by uncomplicated elective CS

Exclusion Criteria

• 1- 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.),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Tranexamic acid	will receive tranexamic acid plus oxytocin
group A	Oxytocin	will receive oxytocin

Primary Outcome Measures

Name	Time	Method
amount of blood loss	baseline	comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS

Secondary Outcome Measures

Name	Time	Method
maternal and neonatal complication	baseline	blood transfusion ,surgical injuries ,