Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients Undergoing Caesarean Section

NCT ID: NCT05110482

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-06-30

Brief Summary

Postpartum hemorrhage (PPH) is the primary cause of nearly one quarter of all maternal deaths globally. Management of uterine tone after delivery involves giving a prophylactic uterotonic and the use of controlled cord traction to facilitate delivery of the placenta and minimize blood loss. Syntocinon and carbetocin are the most commonly used drugs ,During caesarean delivery of stenotic valvular disease patient, the anesthesiologist have an important question: what is the best drug used for prevention of PPH with minimal hemodynamic effect regarding Systemic vascular resistance (SVR), Cardiac out put (COP),Heart rate ( HR), blood pressure? As uterotonic drugs may cause severe hypotension, decrease in SVR and COP that may not be tolerated by these patients .this thesis aims to compare between syntocinon and carbetocin regarding their effect on cardiac output and systemic vascular resistance using cardiometry in cardiac patients with stenotic lesions during caesarean delivery.

Conditions

Adverse Effect of Oxytocic Drugs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

syntocinon group

in this group :5 mL syringe containing a bolus of 1 IU of oxytocin and infusion syringe which will be prepared with a 50 mL syringe containing 0.4 IU/mL of oxytocin and infusion rate of 7.5 IU/h will be administrated to the patient after delivery of the fetus shoulder, Additional bolus syringes will be prepared for use as rescue boluses if needed " which will be 5 ml syringe containing 3 IU of oxytocin

Group Type: ACTIVE_COMPARATOR

Syntocinon

Intervention Type: DRUG

uterotonic drugs

carbetocin group

in this group :5 mL syringe containing a bolus of 100 mcg of carbetocin and infusion syringe " which will be prepared with a 50 mL syringe containing normal saline will be administrated for the patient after delivery of the fetus shoulder. Additional bolus syringes will be prepared for use as rescue boluses if needed which will be 5 ml syringe containing 100 mcg of carbetocin

Group Type: ACTIVE_COMPARATOR

Carbetocin

Intervention Type: DRUG

uterotonic drug

Interventions

Syntocinon

uterotonic drugs

Intervention Type: DRUG

Carbetocin

uterotonic drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pregnant female single tone >38 weeks
• Age :18-45 years old.
• patient with ASA III
• Cardiac patients ( mild and moderate mitral stenosis-aortic stenosis valve disease )

Exclusion Criteria

• Other cardiac conditions (valve regurge, cardiomyopathy, heart failure,severe mitral stenosis, severe aortic stenosis, severe pulmonary hypertension)
• Pregnancy hypertensive disorders (eclampsia,preeclampsia)
• Abnormal placental attachment (accrete,percreta,increta)
• Patients with bleeding disorders
• patient with high risk of postpartum haemorrhage

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherin Refaat

Assistant professor of anesthiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine CAIRO UNIVERISTY

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-247-2020

Identifier Type: -

Identifier Source: org_study_id