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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03247894
Other study ID # KDAR FN Brno 2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2014
Est. completion date August 1, 2017

Study information

Verified date May 2019
Source Brno University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 1, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Czechia Brno University Hospital Brno, Czechia, 62500

Sponsors (2)

Lead Sponsor Collaborator
Brno University Hospital Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months after labour
Primary Multiple sclerosis decompensation/progression Relapse occurence from labour to 6 months after delivery 3 months after labour
Secondary MS progression and the type of anesthetic method MS progression comparison due to the type of anethesia 6 months after labour
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