Effectiveness of Intravenous Tranexamic Acid in Reducing... | NCT02279186

Studies
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section

NCT02279186

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Nov 4, 2014Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Bleeding

Interventions

Tranexamic Acid

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Mar 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Oct 24, 2014

First Submission Date that Met QC Criteria

Oct 28, 2014

First Posted Date

Oct 30, 2014Estimated

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

Nov 1, 2014

Last Update Posted Date

Nov 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Mostafa Abdellah Mostafa, Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial., Ain Shams Maternity HospitalPrincipal Investigator

Lead Sponsor

Ain Shams Maternity HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.

Detailed Description

To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Active Comparator	receiving tranexamic acid	Drug: Tranexamic Acid
group B	No Intervention	does not receive tranexamic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic Acid	Drug	Intravenous Injection	group A	in 200 ml saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of blood loss during cesarean section after placental delivery till end of the operation.		during and 2hours post cesarean section

Secondary Outcomes

Measure	Description	Time Frame
1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .	composite	up to 24hours postoperative
Adverse affect of tranexamic acid on mother and neonate .

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Women undergoing caesarean delivery for various elective indications.
Full term primiparas / multiparas.
Singleton pregnancy being delivered by LSCS.

Exclusion Criteria:

- Medical problems involving the heart, liver, kidney and brain .
Blood disorders.
Allergy to tranexamic acid.
History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
Multiple pregnancy, macrosomia.
Polyhydromnios .
Patients requiring blood transfusion due to anemia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Shalby, MBBCH	Contact	01121117275	202	dr_mahmoud.mostafa@yahoo.com
Amr Abdelaziz, M.D	Contact	01001783383	202	dr_AmrAziz@hotmail.com

Overall Officials

Name	Affiliation	Role
Amr Abdelaziz, M.D	Ain Shams Maternity Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Maternity Hospital	Recruiting	Cairo		02	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided