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

Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients With Stenotic Valvular Heart Disease Undergoing Caesarean Section

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adverse Effect of Oxytocic Drugs
• Intervention / Treatment: Drug: Syntocinon; Drug: Carbetocin

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of medicine CAIRO UNIVERISTY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Syntocinon; uterotonic drugs
Active Comparator: 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	Drug: Carbetocin; uterotonic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output	Average Cardiac output after study drug administration	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systemic vascular resistance	Systemic vascular resistance every 2 minute till end of surgery	intraoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Estimated): June 25, 2023
• Study Completion (Estimated): June 30, 2023

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carbetocin
• Other Study ID Numbers: MD-247-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No