Comparaison of 3 Protocols of Ocytocin Administration in C Section

Overview

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

Full Title of Study: “Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: March 31, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: High doses
    • 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
  • Experimental: Intermediate doses
    • the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 10IU in continuous infusion
  • Experimental: Low doses
    • the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 5 IU in continuous infusion

Clinical Trial Outcome Measures

Primary Measures

  • uterine tone
    • Time Frame: 10 minutes
    • uterine tone juged by the obstetrician

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • necessity of general anesthesia
  • non conscent

Gender Eligibility: Female

including only parturients

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mongi Slim Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mhamed Sami Mebazaa, Professor head of the anesthesia and intensive care department – Mongi Slim Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.