Obstetric Anesthesia and Analgesia and Multiple Sclerosis (OBAANAMS)

May 25, 2019 updated by: Petr Štourač, MD, Brno University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 62500, Czechia, 62500
        • Brno University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Parturients with multiple sclerosis after labour in tertiary perinatology center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after labour
Multiple sclerosis decompensation/progression
Time Frame: 3 months after labour
Relapse occurence from labour to 6 months after delivery
3 months after labour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MS progression and the type of anesthetic method
Time Frame: 6 months after labour
MS progression comparison due to the type of anethesia
6 months after labour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Collaborators

Masaryk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2014

Primary Completion (ACTUAL)

July 31, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (ACTUAL)

August 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 25, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDAR FN Brno 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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