Comparison Study of Oxytocin Versus Tranexamic Acid and E... | NCT05273632

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

NCT05273632

Sponsor

Egymedicalpedia

Status

Completed

Last Update Posted

Feb 8, 2023Actual

Enrollment

300Actual

Phase

Not Applicable

Conditions

Blood Loss, Surgical
Blood Loss, Postoperative

Interventions

Oxytocin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2022Actual

Primary Completion Date

Sep 15, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Dec 2, 2020

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxytocin	Active Comparator	Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision	Drug: Oxytocin
Tranexamic acid and Etamsylate	Active Comparator	Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery	Drug: Oxytocin
Saline	Placebo Comparator	Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section	Drug: Oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	trial of reduction of losing blood intra operative or post operative during Cesarean Delivery	Oxytocin Saline Tranexamic acid and Etamsylate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016063	Blood Loss, Surgical
D019106	Postoperative Hemorrhage
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007431	Intraoperative Complications
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin
D014148	Tranexamic Acid
D004979	Ethamsylate

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided