Comparaison of 3 Protocols of Ocytocin Administration in C Section

August 5, 2019 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 2046
        • Mongi Slim hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Ocytocin
Administration of lower doses of Ocytocin in bolus and 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
Drug: Ocytocin
Administration of lower doses of Ocytocin in bolus and 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
Drug: Ocytocin
Administration of lower doses of Ocytocin in bolus and continuous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mongi Slim Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ocytocin in c section

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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