Multiple SclerosisOBAANAMSNCT03247894
Obstetric Anesthesia and Analgesia and Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Aim of the retrospective study was to evaluate the influence of the labour on the clinical course of the parturients with MS in selected 6 month follow-up interval and to evaluate to possible influence of the different anesthesia/analgesia types on the course of MS. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Data search
- How many people
- 70 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2014to 1 Aug 2017
- How long will I take part?
- 10 Months
- 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 70 years
- Women only
- Adult, Older adult
Study population: Parturients with multiple sclerosis after labour in tertiary perinatology center
Who may be able to join
- Parturients with multiple sclerosis
- Possible follow up - neurologic examination available after 10 month from delivery
Who cannot join
- probable or no multiple sclerosis at time of labor
- unknown neurology history
- unknown data on neurology outcome 6 months after labour
- Incomplete data
- Follow-up not possible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Obstetric Anesthesia and Analgesia on the Progression of the Disease in Multiple Sclerosis Parturients: Retrospective Cohort Study
Aim of the retrospective study was to evaluate the influence of the labour on the clinical course of the parturients with MS in selected 6 month follow-up interval and to evaluate to possible influence of the different anesthesia/analgesia types on the course of MS.
Read the detailed description
The role of anesthesia in multiple sclerosis (MS) progression remains unclear in spite of few foreign studies. The most frequently afflicted patients by MS are women of childbearing age and influence of anesthesia or obstetric epidural analgesia has only not been investigated in Czech Republic. The study aims to retrospectively compare the further course of the disease of MS in patients who labor between 2004 and 2013 in University Hospital Brno either by caesarean section or vaginally with epidural analgesia , with patients who gave birth spontaneously without anesthesia.The aim of the study was to evaluate the influence of the labour on the clinical course of MS and further evaluate the possible influence of the type of anesthesia/analgesia in the peripartal period on the MS progression.
- Conditions
- Multiple Sclerosis
- Being tested
- Data search
- Keywords
- Multiple sclerosis, anesthesia
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data searchOther
Patients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period
| Study group | Role | What they receive |
|---|---|---|
| MS patients who after labour | Patients with multiple sclerosis after labour in tertiary center was screened for progression of MS in 10 months period after labour Receives: Other: Data search |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple sclerosis decompensation/progression at 3rd month
Relapse occurence from labour to 3 months, after delivery was recorded. A relapse was defined as the appearance or worsening of symptoms of neurologic dysfunction lasting more than 24 hours, new lesions on MRI or need of reinforcement in treatment. For disease state after delivery we used dichotomic approach: relapse (at least one) or no relapses.
Measured: 3 months after labour
Multiple sclerosis decompensation/progression
Relapse occurence from labour to 6 months after delivery
Measured: 3 months after labour
Secondary outcomes (1)
MS progression and the type of anesthetic method
MS progression comparison due to the type of anethesia
Measured: 6 months after labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start1 Aug 2014
- Primary completion31 Jul 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Other
- Enrolment
- 70 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247894
- Sponsor's protocol ID
- KDAR FN Brno 2017
- Acronym
- OBAANAMS
- Status last verified
- May 2019
- First submitted
- 4 Aug 2017
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Obstetric Anesthesia and Analgesia on the Progression of the Disease in Multiple Sclerosis Parturients: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03247894
- Acronym / sponsor ID
- OBAANAMS / KDAR FN Brno 2017
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 14 Aug 2017 (actual)
- 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.
Aim of the retrospective study was to evaluate the influence of the labour on the clinical course of the parturients with MS in selected 6 month follow-up interval and to evaluate to possible influence of the different anesthesia/analgesia types on the course of MS.
Detailed description
The role of anesthesia in multiple sclerosis (MS) progression remains unclear in spite of few foreign studies. The most frequently afflicted patients by MS are women of childbearing age and influence of anesthesia or obstetric epidural analgesia has only not been investigated in Czech Republic. The study aims to retrospectively compare the further course of the disease of MS in patients who labor between 2004 and 2013 in University Hospital Brno either by caesarean section or vaginally with epidural analgesia , with patients who gave birth spontaneously without anesthesia.The aim of the study was to evaluate the influence of the labour on the clinical course of MS and further evaluate the possible influence of the type of anesthesia/analgesia in the peripartal period on the MS progression.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patients who after labour | – | Other: Data searchPatients with multiple sclerosis after labour in tertiary center was screened for progression of MS in 10 months period after labour |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Parturients with multiple sclerosis after labour in tertiary perinatology center
Key inclusion criteria (2 listed)
- Parturients with multiple sclerosis
- Possible follow up - neurologic examination available after 10 month from delivery
Key exclusion criteria (5 listed)
- probable or no multiple sclerosis at time of labor
- unknown neurology history
- unknown data on neurology outcome 6 months after labour
- Incomplete data
- Follow-up not possible
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 |
|---|---|---|
| Data searchPatients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period | Other | MS patients who after labour |
Primary outcome
Multiple sclerosis decompensation/progression at 3rd month
Time frame: 3 months after labour
Relapse occurence from labour to 3 months, after delivery was recorded. A relapse was defined as the appearance or worsening of symptoms of neurologic dysfunction lasting more than 24 hours, new lesions on MRI or need of reinforcement in treatment. For disease state after delivery we used dichotomic approach: relapse (at least one) or no relapses.
Multiple sclerosis decompensation/progression
Time frame: 3 months after labour
Relapse occurence from labour to 6 months after delivery
1 secondary outcome
MS progression and the type of anesthetic method
Time frame: 6 months after labour
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 29 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Brno University Hospital at 1 site 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 2 inclusion and 5 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Multiple sclerosis decompensation/progression at 3rd month (time frame: 3 months after labour). The study lists 2 primary outcomes in all. 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 29 May 2019; AzTrials last refreshed its copy on 30 Oct 2026.