Comparaison of 3 Protocols of Ocytocin Administration in C Section

Not Applicable

Completed

• Conditions: Cesarean Section Complications; Oxytocin Adverse Reaction
• Interventions: Drug: Ocytocin

• Registration Number: NCT04046510
• Lead Sponsor: Mongi Slim Hospital

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-03-31
• Status Verified: 2019-07
• Study Completion: 2019-07-31
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-05
• Last Update Submitted: 2019-08-05
• Study First Posted: 2019-08-06
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

• necessity of general anesthesia
• non conscent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermediate doses	Ocytocin	the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 10IU in continuous infusion
Low doses	Ocytocin	the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 5 IU in continuous infusion
High doses	Ocytocin	the patients of this group recieved conventionnal doses of ocytocin after foetal extraction in C section: 5IU in bolus followed by 15IU in continuous infusion

Primary Outcome Measures

Name	Time	Method
uterine tone	10 minutes	uterine tone juged by the obstetrician

Secondary Outcome Measures

Name	Time	Method
hemoglobin rate	30 minutes after C section	delta hemoglobin: preoperative HB- Post operative HB
side effects of Ocytocin	up to 30 minutes after C section	Tachycardia, hypotension, nausea vomiting, headache, chest pain
Additive boluses of Ocytocin	30 minutes after C section	necessity of Additive boluses of Ocytocin

Trial Locations

Locations (1)

Mongi Slim Hospital; 🇹🇳 Tunis, Tunisia