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Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02044549
Enrollment
300
Registered
2014-01-24
Start date
2014-06-30
Completion date
2015-12-31
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Postpartum Hemorrhage

Keywords

Carbetocin, syntometrine, postpartum hemorrhage, cesarean section

Brief summary

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

Detailed 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

Interventions

DRUGcarbetocin

Oxycontin analogue

Uterotonins

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
prevention of post partum hemorrhage after CS24 hoursNumber of participants experienced postpartum hemorrhage

Secondary

MeasureTime frameDescription
side effects of drugs used24 hoursNumber 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026