Complication of Labor and/or DeliveryNCT02447757
Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth
An observational study of Complication of Labor and/or Delivery, run by Brno University Hospital at 2 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complication of Labor and/or Delivery
- What is being tested?
- remifentanil
- How many people
- 66 participants
- Where
- 2 sitesCzechia
- Study dates
- Jan 2010to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Parturients during the delivery
Who may be able to join
- parturients during the delivery
- administered remifentanil analgesia
- signed informed consent
Who cannot join
- informed consent not signed
- missing data about the analgetic method a analgetic efficacy
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
KDAR - department of pediatrics anesthesia and resuscitation
Brno, Brno, 62500
Sokolov Hospital
Sokolov, 356 01
About this study
Official title: Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth: Retrospective Observational Study
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.
Read the detailed description
In retrospective observational study will authors search the documentation of parturients. The cohort size is estimated to 100 subjects, in period between 2010-2014. Excluded will be all patients who did not signed the informed consent for processing with their medical data.The main aim is to evaluate the efficacy of the remifentanil analgesia in parturients in the first phase of delivery.
The analgesic efficacy will be evaluated by the change in VAS (visual analogue scale) score after induction of remifentanil analgesia Satisfaction will be evaluated by the questionary.
- Conditions
- Complication of Labor and/or Delivery
- Being tested
- remifentanil
- Keywords
- Remifentanil, delivery, childbirth, analgesia, parturition, confinement
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
Remifentanil analgesia during delivery
| Study group | Role | What they receive |
|---|---|---|
| Parturients with remifentanil analgesia | Parturients after induction of remifentanyl analgesia during the delivery Receives: Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Patients will fill the questionaire to obtain their opinion on the remifentanil analgesia
Measured: Before initiation of anagetic method (first phase of delivery) and 1hour after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Labor and/or DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sokolov
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447757
- Sponsor's protocol ID
- KDAR Sokolov
- Status last verified
- Jul 2016
- First submitted
- 15 May 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT02447757
- Acronym / sponsor ID
- KDAR Sokolov
- Conditions
- Complication of Labor and/or Delivery
- Keywords
- Remifentanil, delivery, childbirth, analgesia, parturition, confinement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Hospital Sokolov
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In retrospective observational study will authors search the documentation of parturients. The cohort size is estimated to 100 subjects, in period between 2010-2014. Excluded will be all patients who did not signed the informed consent for processing with their medical data.The main aim is to evaluate the efficacy of the remifentanil analgesia in parturients in the first phase of delivery.
The analgesic efficacy will be evaluated by the change in VAS (visual analogue scale) score after induction of remifentanil analgesia Satisfaction will be evaluated by the questionary.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients with remifentanil analgesia | – | Drug: remifentanilParturients after induction of remifentanyl analgesia during the delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parturients during the delivery
Key inclusion criteria (3 listed)
- parturients during the delivery
- administered remifentanil analgesia
- signed informed consent
Key exclusion criteria (2 listed)
- informed consent not signed
- missing data about the analgetic method a analgetic efficacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remifentanilRemifentanil analgesia during delivery | Drug | Parturients with remifentanil analgesia |
Primary outcome
Efficacy of remifentanyl analgesia during the delivery
Time frame: VAS score before the induction of remifentanyl infusion and 1hour after initiation of remifentanil analgesia during the first phase of delivery
To evaluate the efficacy of remifentanil analgesia during the first phase of delivery in parturients by observing changes in VAS score
1 secondary outcome
Patient satisfaction with analgetic method
Time frame: Before initiation of anagetic method (first phase of delivery) and 1hour after childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Labor and/or Delivery, run by Brno University Hospital at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of remifentanyl analgesia during the delivery (time frame: VAS score before the induction of remifentanyl infusion and 1hour after initiation of remifentanil analgesia during the first phase of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.