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Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

NCT03777878 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-02-15

No results posted yet for this study

Summary

Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.

Conditions

  • Cesarean Section Complications

Interventions

DRUG

Carbetocin

100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby

DRUG

oxytocin

20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

DRUG

TA

2 ampoules of TA in 100 ml saline by slow infusion

DRUG

placebo to carbetocin

placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby

DRUG

placebo to TA

2 placebo ampoules to TA in 100 ml saline by slow infusion

DRUG

placebo to oxytocin

two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

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
2019-01-01
Primary Completion
2021-03-30
Completion
2021-05-01

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 NCT03777878 on ClinicalTrials.gov