Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)

February 5, 2023 updated by: Egymedicalpedia

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Placebo to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant females admitted for Elective Cesarean Section.
  • Gestational age of pregnancy (38 weeks To 40 weeks).
  • the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
  • Singleton living fetus.
  • No medical disorders.
  • Informed Oral Consent From The Patient.

Exclusion Criteria:

  • Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits).
  • Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
  • Acute liver or kidney diseases; blood disorders, such as anaemia.
  • Allergy to Tranexamic acid.
  • Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
  • Ante partum Hemorrhage such placental abruption.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Oxytocin
Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision
Drug: Oxytocin
trial of reduction of losing blood intra operative or post operative during Cesarean Delivery
Other Names:
  • Tranexamic acid and Etamsylate
ACTIVE_COMPARATOR: Tranexamic acid and Etamsylate
Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery
Drug: Oxytocin
trial of reduction of losing blood intra operative or post operative during Cesarean Delivery
Other Names:
  • Tranexamic acid and Etamsylate
PLACEBO_COMPARATOR: Saline
Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section
Drug: Oxytocin
trial of reduction of losing blood intra operative or post operative during Cesarean Delivery
Other Names:
  • Tranexamic acid and Etamsylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss during and after cesarean delivery
Time Frame: First 2 hours after C-Section
Measuring of Hemoglobin level and Hematocrit level pre and post operatively.
First 2 hours after C-Section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative bleeding
Time Frame: first 24 hours after C-Section
assessment of Hemoglobin level and Hematocrit level post operatively.
first 24 hours after C-Section

Collaborators and Investigators

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

Sponsor

Egymedicalpedia

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 (ACTUAL)

March 20, 2022

Primary Completion (ACTUAL)

September 15, 2022

Study Completion (ACTUAL)

September 30, 2022

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

March 9, 2022

First Posted (ACTUAL)

March 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 5, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EL-SAYED EL-DESOUKY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Blood Loss, Surgical

Clinical Trials on Oxytocin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe