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

Phase 4

• Conditions: Adverse Effect of Oxytocic Drugs
• Interventions: Drug: Carbetocin; Drug: Syntocinon

• Registration Number: NCT05110482
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-08
• Study Start: 2021-11-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-03
• Last Update Posted: 2023-06-06
• Primary Completion: 2023-06-25
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 38

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 )

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbetocin group	Carbetocin	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
syntocinon group	Syntocinon	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

Primary Outcome Measures

Name	Time	Method
Cardiac output	intraoperative	Average Cardiac output after study drug administration

Secondary Outcome Measures

Name	Time	Method
systemic vascular resistance	intraoperative	Systemic vascular resistance every 2 minute till end of surgery

Trial Locations

Locations (1)

Faculty of medicine CAIRO UNIVERISTY; 🇪🇬 Cairo, Egypt