MSFrontier

EPID Multiple Sclerosis Pregnancy Study

Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
CompletedMS (type not specified)NCT02749396

What it found

No result found

We found no results in the registry or in papers.

This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Elective TOPFA for other reasons than IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Elective termination for other reasonsthan IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Stillbirth due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Live birth while different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • MCA due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of live birth due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of MCA due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

Other measures (6)

  • Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Prevalence of elective TOPFA stratified by specific patient characteristics

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Prevalence of stillbirth stratified by specific patient characteristics

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Prevalence of live birth stratified by specific patient characteristics

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Prevalence of MCA stratified by specific patient characteristics

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

Who could take part

MS (type not specified)

Inclusion Criteria: * Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.

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History

    1. Started

      May 2016

    2. Main results due

      Aug 2018

    3. Finished

      Aug 2018

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