Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

NCT ID: NCT03351686

Last Updated: 2017-11-27

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-04-15

Brief Summary

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postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .

Detailed Description

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Conditions

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Postpartum Hemorrhage

Keywords

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tranexamic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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tranexamic acid group

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.

non tranexamic (control) group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic Acid

Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Gestational age of 28 weeks or more.
* Chronic Hypertension.
* Preeclapmsia -Eclampsia.
* Multiple pregnancy.
* Uterine Liomyomas.
* Polyhydraminos.
* Fetal macrosomia.
* Associated Thrombocytopenia
* History of postpartum hemorrhage.

Exclusion Criteria

* Patients with rheumatic heart disease.
* Patients with history Cardiac Valve Replacement.
* Current or past history of DVT.
* Women on any anticoagulant therapy.
* Sensitivity to tranexamic acid
* Pregnancies with any abnormally implanted or located placenta.
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Hanan Nabil

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanan Nabil, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Other Identifiers

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MansuraU

Identifier Type: -

Identifier Source: org_study_id