Prevention of Postpartum Haemorrhage

NCT ID: NCT04463966

Last Updated: 2020-07-09

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-05-31

Brief Summary

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Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

Detailed Description

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This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage \& reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. \& reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.

Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study

Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .

Control

control group will not be given tranexamic acid

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic acid injection

1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .

Intervention Type DRUG

Other Intervention Names

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Kapron, 500 mg/5ml

Eligibility Criteria

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Inclusion Criteria

* Women at high risk for postpartum hemorrhage after cesarean section

Exclusion Criteria

* women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Abou Bakr Mohamed El Nashaar

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaimaa Ezzat

Role: PRINCIPAL_INVESTIGATOR

Police Hospital

Locations

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Police Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aboubakr Elnashar, MD

Role: CONTACT

00201066934749

shaimaa ezzat

Role: CONTACT

00201009023289

Facility Contacts

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Shaimaa ezzat

Role: primary

00201009023289

Other Identifiers

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Tranexamic

Identifier Type: -

Identifier Source: org_study_id

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