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

Primary Purpose

Blood Loss, Surgical, Blood Loss, Postoperative

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Oxytocin

About this trial

This is an interventional treatment trial for Blood Loss, Surgical focused on measuring blood loss, cesarean section, oxytocin, tranexamic acid, etamsylate, saline, Intra-operative, Postoperative

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oxytocin

Tranexamic acid and Etamsylate

Saline

Arm Description

Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision

Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery

Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section

Outcomes

Primary Outcome Measures

blood loss during and after cesarean delivery

Measuring of Hemoglobin level and Hematocrit level pre and post operatively.

Secondary Outcome Measures

post operative bleeding

assessment of Hemoglobin level and Hematocrit level post operatively.

Full Information

NCT ID

NCT05273632

First Posted

December 2, 2020

Last Updated

February 5, 2023

Sponsor

Egymedicalpedia

1. Study Identification

Unique Protocol Identification Number

NCT05273632

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

March 20, 2022 (Actual)

Primary Completion Date

September 15, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

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

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

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.

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, etamsylate, saline, Intra-operative, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Active Comparator

Arm Description

Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision

Arm Title

Tranexamic acid and Etamsylate

Arm Type

Active Comparator

Arm Description

Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Other Intervention Name(s)

Tranexamic acid and Etamsylate

Intervention Description

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Primary Outcome Measure Information:

Title

blood loss during and after cesarean delivery

Description

Measuring of Hemoglobin level and Hematocrit level pre and post operatively.

Time Frame

First 2 hours after C-Section

Secondary Outcome Measure Information:

Title

post operative bleeding

Description

assessment of Hemoglobin level and Hematocrit level post operatively.

Time Frame

first 24 hours after C-Section

10. Eligibility

Sex

Female

Gender Based

Yes

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 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.

Facility Information:

Facility Name

Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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