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Obstetric Anesthesia and Analgesia and Multiple Sclerosis (OBAANAMS)

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ClinicalTrials.gov Identifier: NCT03247894
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Faculty of medicine, Masaryk University Brno
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Data search

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 Type : Observational [Patient Registry]
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Months
Official Title: Influence of Obstetric Anesthesia and Analgesia on the Progression of the Disease in Multiple Sclerosis Parturients: Retrospective Cohort Study
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other: Data search
Patients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period




Primary Outcome Measures :
  1. 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.

  2. Multiple sclerosis decompensation/progression [ Time Frame: 3 months after labour ]
    Relapse occurence from labour to 6 months after delivery


Secondary Outcome Measures :
  1. MS progression and the type of anesthetic method [ Time Frame: 6 months after labour ]
    MS progression comparison due to the type of anethesia



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Parturients with multiple sclerosis
Sampling Method:   Non-Probability Sample
Study Population
Parturients with multiple sclerosis after labour in tertiary perinatology center
Criteria

Inclusion Criteria:

  • Parturients with multiple sclerosis
  • Possible follow up - neurologic examination available after 10 month from delivery

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247894


Locations
Czechia
Brno University Hospital
Brno, Czechia, 62500, Czechia, 62500
Sponsors and Collaborators
Brno University Hospital
Faculty of medicine, Masaryk University Brno

Responsible Party: Petr Štourač, MD, doc.MD. Ph.D., Brno University Hospital
ClinicalTrials.gov Identifier: NCT03247894     History of Changes
Other Study ID Numbers: KDAR FN Brno 2017
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Petr Štourač, MD, Brno University Hospital:
Multiple sclerosis, anesthesia

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs