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

Adverse Effect of Oxytocic Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05110482
• Other study ID #: MD-247-2020
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: November 30, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38
• Est. completion date: June 30, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect of Oxytocic Drugs
• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Syntocinon
uterotonic drugs
• Carbetocin
uterotonic drug

Locations

Country	Name	City	State
Egypt	Faculty of medicine CAIRO UNIVERISTY	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	Average Cardiac output after study drug administration	intraoperative
Secondary	systemic vascular resistance	Systemic vascular resistance every 2 minute till end of surgery	intraoperative