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Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

Primary Purpose

Blood Loss, Surgical, Blood Loss, Postoperative

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Oxytocin ,Tranexamic acid and Ethamsylate
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical focused on measuring blood loss, Cesarean Section, Oxytocin, Tranexamic acid(Kapron), Etamsylate(Dicynon).

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Pregnant females admitted for elective Cesarean Section.
  2. Gestational age (38 to 41 weeks).
  3. Age of the participants: 20 to 40 years.
  4. Body Mass Index (18.5 - 29.9).
  5. Singleton living fetus.
  6. No medical disorders.
  7. Informed written consent from the candidates.

Exclusion criteria:

  1. - 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).
  2. -Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
  3. -Acute and chronic liver or kidney diseases; blood disorders, such as anemia.
  4. -Allergy to Tranexamic acid or any drug used.
  5. -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.
  6. - Abnormal placentae such as placenta previa and placental abruption.
  7. -Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion.
  8. - Patients who refused spinal anesthesia.

Sites / Locations

  • Sayed Galal Hospital and Shoubra General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oxytocin(only)

Tranexamic acid and Ethamsylate

Arm Description

oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section

Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section

Outcomes

Primary Outcome Measures

Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.

Secondary Outcome Measures

Sever PPH as bleeding is >1000 cc
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.

Full Information

First Posted
November 26, 2020
Last Updated
March 1, 2022
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT04656067
Brief Title
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate
Official Title
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration.
Detailed Description
Caesarean Delivery commonly referred to as caesarean section and occasionally caesarean birth is defined as the delivery of a foetus(es) through surgical incisions made through the anterior abdominal wall (technically referred to as laparotomy) and the anterior uterine wall (technically denoted to as hysterotomy). Obstetric Hemorrhage (Intra operative OR post operative bleeding)is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. And accounts for 50% of maternal mortality in low-income countries. So many Strategies reducing the intraoperative blood loss or post operative blood loss could be helpful in decreasing the risks of blood transfusion and the postoperative maternal morbidity. So these Medications are such as Oxytocin, Carbetocin, Misoprostol, Prostaglandin F2 alpha, methylergonovine, Tranexamic acid and Etamsylate . have been tried before to control bleeding during and after Cesarean Section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Blood Loss, Postoperative
Keywords
blood loss, Cesarean Section, Oxytocin, Tranexamic acid(Kapron), Etamsylate(Dicynon).

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin(only)
Arm Type
Active Comparator
Arm Description
oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section
Arm Title
Tranexamic acid and Ethamsylate
Arm Type
Active Comparator
Arm Description
Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section
Intervention Type
Drug
Intervention Name(s)
Oxytocin ,Tranexamic acid and Ethamsylate
Other Intervention Name(s)
Syntocinon , Kapron, Dicynon
Intervention Description
Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate
Primary Outcome Measure Information:
Title
Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
Description
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.
Time Frame
First 2 hours after C-Section
Secondary Outcome Measure Information:
Title
Sever PPH as bleeding is >1000 cc
Description
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.
Time Frame
first 24 hours after C-Section

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant females admitted for elective Cesarean Section. Gestational age (38 to 41 weeks). Age of the participants: 20 to 40 years. Body Mass Index (18.5 - 29.9). Singleton living fetus. No medical disorders. Informed written consent from the candidates. Exclusion criteria: - 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, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal). -Acute and chronic liver or kidney diseases; blood disorders, such as anemia. -Allergy to Tranexamic acid or any drug used. -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage. - Abnormal placentae such as placenta previa and placental abruption. -Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion. - Patients who refused spinal anesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.,AbdelSattar M Farhan, Professor
Organizational Affiliation
Al-Azhar University, Faculty of medicine for boys
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr.,ElSayed A. ElDesouky, Professor
Organizational Affiliation
Al-Azhar University, Faculty of medicine for boys
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sayed Galal Hospital and Shoubra General Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Etamsylate .

Learn more about this trial

Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate

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