The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery

NCT ID: NCT01085006

Last Updated: 2011-01-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

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Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.

Detailed Description

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Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic acid

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Tranexamic acid in cases, normal saline in controls

normal saline infusion

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Tranexamic acid in cases, normal saline in controls

Interventions

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Tranexamic acid

Tranexamic acid in cases, normal saline in controls

Intervention Type DRUG

Normal saline

Tranexamic acid in cases, normal saline in controls

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Term pregnancy
2. Single fetus
3. Maximally only one previous cesarean delivery

Exclusion Criteria

1. More than one previous cesarean delivery
2. Hx of other abdominal or pelvic surgery
3. Hx of medical disorders
4. Hx of thromboembolic disorders
5. Polyhydramnios
6. Macrosomia
7. Preeclampsia
8. Hx of sensitivity to Tranexamic acid
9. Abnormal Pt, PTT, PT or INR
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Associated Prof

Principal Investigators

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Laleh Eslamian, MD

Role: PRINCIPAL_INVESTIGATOR

Associated Prof, Obstetrician & Gynecologist

Locations

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Laleh Eslamian

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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830

Identifier Type: -

Identifier Source: org_study_id

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