Comparaison of 3 Protocols of Ocytocin Administration in C Section

Cesarean Section Complications Clinical Trial

Official title:

Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046510
• Other study ID #: Ocytocin in c section
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2019
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia

Description:

This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia.

The aim was to determine the lowest efficient dose to prevent post partum hemorrage and with the lowest incidence of maternal side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients scheduled for C section under spinal anesthesia, monofoetal pregnancy, full term

Exclusion Criteria:

• necessity of general anesthesia

• non conscent

Related Conditions & MeSH terms

• Cesarean Section Complications
• Oxytocin Adverse Reaction

Intervention

Drug:
• Ocytocin
Administration of lower doses of Ocytocin in bolus and continuous infusion

Locations

Country	Name	City	State
Tunisia	Mongi Slim Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uterine tone	uterine tone juged by the obstetrician	10 minutes
Secondary	hemoglobin rate	delta hemoglobin: preoperative HB- Post operative HB	30 minutes after C section
Secondary	Additive boluses of Ocytocin	necessity of Additive boluses of Ocytocin	30 minutes after C section
Secondary	side effects of Ocytocin	Tachycardia, hypotension, nausea vomiting, headache, chest pain	up to 30 minutes after C section