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The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women

NCT03820206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-01-06

No results posted yet for this study

Summary

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed.According to group assignment, either 1 g(10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h)

Conditions

  • Intraoperative Bleeding

Interventions

DRUG

Tranexamic Acid

1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

PROCEDURE

Cesarean section

Lower segement transverse cesarean section

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2019-11-15
Completion
2020-01-02

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03820206 on ClinicalTrials.gov