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

NCT ID: NCT02279186

Last Updated: 2014-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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group A

receiving tranexamic acid

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Intravenous Injection

group B

does not receive tranexamic acid

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic Acid

Intravenous Injection

Intervention Type DRUG

Other Intervention Names

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in 200 ml saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Mostafa Abdellah Mostafa

Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr Abdelaziz, M.D

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Maternity Hospital

Locations

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Ain Shams Maternity Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Shalby, MBBCH

Role: CONTACT

01121117275 ext. 202

Amr Abdelaziz, M.D

Role: CONTACT

01001783383 ext. 202

Facility Contacts

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Nashwa AlSaied, M.D

Role: primary

01005369353 ext. 202

Amr Abdelaziz, M.D

Role: backup

01001783383 ext. 202

Other Identifiers

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septemper 2014

Identifier Type: -

Identifier Source: org_study_id

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