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

Primary Purpose

Adverse Effect of Oxytocic Drugs

Status
Enrolling by invitation
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Syntocinon
Carbetocin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adverse Effect of Oxytocic Drugs

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine CAIRO UNIVERISTY

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

syntocinon group

carbetocin group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cardiac output
Average Cardiac output after study drug administration

Secondary Outcome Measures

systemic vascular resistance
Systemic vascular resistance every 2 minute till end of surgery

Full Information

First Posted
September 28, 2021
Last Updated
June 3, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05110482
Brief Title
Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients Undergoing Caesarean Section
Official Title
Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients With Stenotic Valvular Heart Disease Undergoing Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
June 25, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect of Oxytocic Drugs

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
syntocinon group
Arm Type
Active Comparator
Arm Description
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
Arm Title
carbetocin group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Syntocinon
Intervention Description
uterotonic drugs
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
uterotonic drug
Primary Outcome Measure Information:
Title
Cardiac output
Description
Average Cardiac output after study drug administration
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
systemic vascular resistance
Description
Systemic vascular resistance every 2 minute till end of surgery
Time Frame
intraoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant females presented for caesarean delivery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Faculty of medicine CAIRO UNIVERISTY
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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