NCT01085006

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 25, 2011

Completed
Last Updated

January 25, 2011

Status Verified

November 1, 2010

Enrollment Period

11 months

First QC Date

March 10, 2010

Results QC Date

January 2, 2011

Last Update Submit

January 2, 2011

Conditions

Hemorrhage

Keywords

cesarean deliveryTranexamic acidhemorrhageSpinal analgesia1-the amount of hemorrhage during cesarean delivery2-the amount of hemorrhage in the first 2 hours of cesarean delivery3-the amount of hemorrhage in the first 24 hour after cesarean delivery

Outcome Measures

Primary Outcomes (1)

  • The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward

    During the procedure and within 2 hours afterwards

Secondary Outcomes (1)

  • Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery

    First 24 hours

Study Arms (2)

Tranexamic acid

EXPERIMENTAL
Drug: Tranexamic acid

normal saline infusion

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

Tranexamic acidDRUG

Tranexamic acid in cases, normal saline in controls

Tranexamic acid
Normal salineDRUG

Tranexamic acid in cases, normal saline in controls

normal saline infusion

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Term pregnancy
  • Single fetus
  • Maximally only one previous cesarean delivery

You may not qualify if:

  • More than one previous cesarean delivery
  • Hx of other abdominal or pelvic surgery
  • Hx of medical disorders
  • Hx of thromboembolic disorders
  • Polyhydramnios
  • Macrosomia
  • Preeclampsia
  • Hx of sensitivity to Tranexamic acid
  • Abnormal Pt, PTT, PT or INR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laleh Eslamian

Tehran, 14114, Iran

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Laleh Eslamian
Organization
Tehran University of Medical Sciences
leslamian@tums.ac.ir
+982184902415

Study Officials

  • Laleh Eslamian, MD

    Associated Prof, Obstetrician & Gynecologist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

September 1, 2009

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

January 25, 2011

Results First Posted

January 25, 2011

Record last verified: 2010-11

Locations

IR(1)