Comparaison of 3 Protocols of Ocytocin Administration in C Section

NCT ID: NCT04046510

Last Updated: 2019-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Cesarean Section Complications Oxytocin Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
pre filled syringues of ocytocin were given to the care provider who didn't know the exact amount of ocytocin bolus and continious infusion

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ocytocin

Intervention Type DRUG

Administration of lower doses of Ocytocin in bolus and continuous infusion

Intermediate doses

the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 10IU in continuous infusion

Group Type EXPERIMENTAL

Ocytocin

Intervention Type DRUG

Administration of lower doses of Ocytocin in bolus and continuous infusion

Low doses

the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 5 IU in continuous infusion

Group Type EXPERIMENTAL

Ocytocin

Intervention Type DRUG

Administration of lower doses of Ocytocin in bolus and continuous infusion

Interventions

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Ocytocin

Administration of lower doses of Ocytocin in bolus and continuous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* necessity of general anesthesia
* non conscent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

Professor head of the anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mongi Slim Hospital

Tunis, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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Ocytocin in c section

Identifier Type: -

Identifier Source: org_study_id

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