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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02749396
Date of registration:	20/04/2016
Prospective Registration:	Yes
Primary sponsor:	Bayer
Public title:	EPID Multiple Sclerosis Pregnancy Study
Scientific title:	Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon ß - a Register-based Study in the Nordic Countries
Date of first enrolment:	May 2, 2016
Target sample size:	2089
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02749396
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Finland

Contacts

Name:	Bayer Study Director
Address:
Telephone:
Email:
Affiliation:	Bayer

Key inclusion & exclusion criteria

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.

Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)

Other: No MSDMDs therapy (control)

Drug: Extavia (interferon beta-1b), Novartis Pharma AG

Drug: Avonex (interferon beta-1a), Biogen Idec Ltd

Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd

Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd

Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG

Primary Outcome(s)

Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Stillbirth due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Comparison of the prevalence of stillbirth due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

MCA due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Comparison of the prevalence of live birth due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Live birth while different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Comparison of the prevalence of MCA due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Elective termination for other reasonsthan IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Elective TOPFA for other reasons than IFN-ß exposure [Time Frame: 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-ß exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Serious adverse pregnancy outcome due to different regimes of IFN-ß exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Secondary Outcome(s)

Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Prevalence of elective TOPFA stratified by specific patient characteristics [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Prevalence of stillbirth stratified by specific patient characteristics [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Prevalence of live birth stratified by specific patient characteristics [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Prevalence of MCA stratified by specific patient characteristics [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-ß exposure [Time Frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years]

Secondary ID(s)

18219

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Serono Europe Ltd

Biogen

EPID Research

Novartis Pharmaceuticals

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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