NCT02447757

Brief Summary

Retrospective observational study to determine the efficacy of remifentanil during the delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100 parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia induction) and parturients satisfaction with the method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

5 years

First QC Date

May 15, 2015

Last Update Submit

July 22, 2016

Conditions

Complication of Labor and/or Delivery

Keywords

Remifentanil, delivery, childbirth, analgesia, parturition, confinement

Outcome Measures

Primary Outcomes (1)

  • Efficacy of remifentanyl analgesia during the delivery

    To evaluate the efficacy of remifentanil analgesia during the first phase of delivery in parturients by observing changes in VAS score

    VAS score before the induction of remifentanyl infusion and 1hour after initiation of remifentanil analgesia during the first phase of delivery

Secondary Outcomes (1)

  • Patient satisfaction with analgetic method

    Before initiation of anagetic method (first phase of delivery) and 1hour after childbirth

Study Arms (1)

Parturients with remifentanil analgesia

Parturients after induction of remifentanyl analgesia during the delivery

Drug: remifentanil

Interventions

remifentanilDRUG

Remifentanil analgesia during delivery

Parturients with remifentanil analgesia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Parturients during the delivery

You may qualify if:

  • parturients during the delivery
  • administered remifentanil analgesia
  • signed informed consent

You may not qualify if:

  • informed consent not signed
  • missing data about the analgetic method a analgetic efficacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KDAR - department of pediatrics anesthesia and resuscitation

Brno, Brno, 62500, Czechia

Location

Sokolov Hospital

Sokolov, 356 01, Czechia

Location

MeSH Terms

Conditions

Agnosia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

February 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

CZ(2)