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Completed

NCT Number: NCT03247894

Obstetric Anesthesia and Analgesia and Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Brno University Hospital

Brno, Czechia, 62500, Czechia, 62500

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data search

Other

Patients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period

Primary outcomes

  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 outcomes

  1. MS progression and the type of anesthetic method

    Time frame: 6 months after labour

    MS progression comparison due to the type of anethesia

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Collaborators

  • Masaryk University

Registry information

Official study title

Influence of Obstetric Anesthesia and Analgesia on the Progression of the Disease in Multiple Sclerosis Parturients: Retrospective Cohort Study

Acronym: OBAANAMS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2017
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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