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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

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:

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.

Sites / Locations

Sayed Galal Hospital and Shoubra General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT04656067

First Posted

November 26, 2020

Last Updated

March 1, 2022

Sponsor

Egymedicalpedia

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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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