Comparaison of 3 Protocols of Ocytocin Administration in C Section

Study Overview
=================
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.

Official Title
-----------------
Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section

Conditions
-----------------
Cesarean Section Complications, Oxytocin Adverse Reaction

Intervention / Treatment
-----------------
* Drug: Ocytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients scheduled for C section under spinal anesthesia, monofoetal pregnancy, full term Exclusion Criteria: necessity of general anesthesia non conscent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High doses<br>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 | Drug: Ocytocin<br>* Administration of lower doses of Ocytocin in bolus and continuous infusion<br>|
| Experimental: Intermediate doses<br>the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 10IU in continuous infusion | Drug: Ocytocin<br>* Administration of lower doses of Ocytocin in bolus and continuous infusion<br>|
| Experimental: Low doses<br>the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 5 IU in continuous infusion | Drug: Ocytocin<br>* Administration of lower doses of Ocytocin in bolus and continuous infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine tone | uterine tone juged by the obstetrician | 10 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean section, ocytocin, uterine tone, side effects