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NCT02044549 Clinical Trial

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Postpartum Hemorrhage Clinical Trial

Official title:
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02044549
Other study ID # Carbitocin
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2014
Est. completion date December 2015

Study information
Verified date June 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Description:

A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal. Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: - All participants are at 37 - 40 weeks of gestational age - Noncomplicated pregnancy. Exclusion Criteria: - Participants with placenta previa - Patients with coagulopathy - preeclamptic women - known sensitivity to oxytocin or methergine were excluded

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• carbetocin
Oxycontin analogue
• Syntometrine
Uterotonins

Locations
Country Name City State
Egypt Ahmed Maged Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevention of post partum hemorrhage after CS Number of participants experienced postpartum hemorrhage 24 hours
Secondary side effects of drugs used Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching 24 hours
See also
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Completed NCT02079558 - Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section Phase 2
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Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
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Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4
Completed NCT02910310 - Introduction of UBT for PPH Management in Three Countries N/A