Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa

February 21, 2017 updated by: Ahmed Elsayed Hassan Elbohoty, Ain Shams University

Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa: A Randomized Controlled Trial

Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa to detect efficacy of Tranexamic acid in decreasing blood loss

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term pregnancy (more than 37 weeks of gestation)
  • Diagnosis of placenta previa was confirmed by ultrasound
  • The patient hemoglobin percentage is more than 10 mg/dl

Exclusion Criteria:

  • Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
  • Emergency lower segment cesarean section
  • Associated medical comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cases
Tranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa
Drug: Tranexamic acid
10 mg/kg body weight will be given with induction of anesthesia by intravenous infusion
NO_INTERVENTION: Controls
Control group will not receive Tranexamic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intra operative blood loss in ml
Time Frame: intraoperative during cesarean section
Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss
intraoperative during cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAbdelaziz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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