Determination of Blood Loss After CS

September 14, 2020 updated by: Noha Mahmoud Abu Shata, Ain Shams University

Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
will receive oxytocin
Drug: Oxytocin
Oxytocin
Active Comparator: group B
will receive tranexamic acid plus oxytocin
Drug: Tranexamic acid
comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
Other Names:
  • oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of blood loss
Time Frame: baseline
comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal and neonatal complication
Time Frame: baseline
blood transfusion ,surgical injuries ,
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • blood loss after CS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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