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

NCT05110482 | Unknown Phase 4

• 1 other identifier: MD-247-2020
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cardiac output

  Average Cardiac output after study drug administration

  intraoperative

Secondary Outcomes (1)

• systemic vascular resistance

  intraoperative

Study Arms (2)

syntocinon group

ACTIVE COMPARATOR

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

carbetocin group

ACTIVE COMPARATOR

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

Interventions

Syntocinon DRUG

uterotonic drugs

syntocinon group

Carbetocin DRUG

uterotonic drug

carbetocin group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant females presented for caesarean delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine CAIRO UNIVERISTY

Cairo, Egypt

Location

MeSH Terms

Interventions

Oxytocin; carbetocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthiology

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 8, 2021
• Study Start: November 30, 2021
• Primary Completion: June 25, 2023
• Study Completion: June 30, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

EG (1)