Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Post Partum Hemorrhage Clinical Trial

Official title:

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693599
• Other study ID #: carbetocin
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• 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 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 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: 1200
• Est. completion date: September 30, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All participants are at 37 - 40 weeks of gestational age

• Noncomplicated pregnancy.

• obese women with BMI > 30.

Exclusion Criteria:

• Participants with placenta previa,

• coagulopathy,

• preeclamptic

• known sensitivity to carbetocin,oxytocin or methergine were excluded

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• carbetocin
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
• Syntometrine
one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes

Locations

Country	Name	City	State
Egypt	faculty of medicine Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postpartum hemorrhage after CS	Number of participants experienced massive postpartum hemorrhage	24 hours
Secondary	side effects of drugs used	GIT side effects as nausea , vomiting	24 hours