The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the German Patient Support Program (PSP) and of whom a pregnancy report and pregnancy outcome report is available. The secondary objectives of this study are applicable for a subpopulation of the above-mentioned population, i.e. for participants of whom data on a standardized questionnaire collected during a telephone interview is available.
This is an observational study with focus on existing pregnancy reporting forms (retrospective part) and a patient's questionnaire which is completed at a single point of time (prospective part). Main data source for the retrospective data (from 2014 until December 2019) will be captured from multiple sclerosis service-center (MSSC) database, i.e. the entered pregnancy report (to be completed as soon as pregnancy becomes known) and pregnancy outcomes report (to be completed after completion of pregnancy). Prospective data (December 2020 to 31 March 2021) will be captured as standardized ePDF questionnaire completed during telephone interview. If the pregnancy report or the pregnancy outcome report is incomplete, i.e. the data above was not collected, the open questions will be addressed during a telephone interview performed by the MSSC and the new information will be entered into the MSCC database. The patient questionnaire will be completed at a single point of time during the telephone interview performed by the MSSC.
Study Type
OBSERVATIONAL
Enrollment
470
Administered as specified in the treatment arm.
Research Site
Göttingen, Germany
Percentage of Participants With Live Births Without Congenital Anomalies
Time frame: up to end of study (4 months)
Percentage of Participants With Live Births With Congenital Anomalies
Time frame: up to end of study (4 months)
Percentage of Participants With Ectopic Pregnancies
Time frame: 8 weeks of gestation
Percentage of Participants With Spontaneous Abortions
A spontaneous abortion is defined as fetal death before 22 weeks of gestation.
Time frame: up to 22 weeks of gestation
Percentage of Participants With Elective Abortions
Time frame: up to Week 20 of gestation
Percentage of Participants With Preterm Births
A preterm birth is a birth before 37 completed weeks of gestation.
Time frame: up to 37 weeks of gestation
Percentage of Participants With Stillbirths
A still birth is defined as fetal death at \>22 weeks gestation.
Time frame: from 22 week up to 39 weeks of gestation
Average Weight of the Children
Time frame: From Birth up to Month 48
Average Length of the Children
Time frame: From Birth up to Month 48
Average Head Circumference of the Children
Time frame: From Birth up to Month 48
Percentage of Abnormalities Diagnosed During Pediatric Check-ups
Time frame: up to Month 48
Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
Time frame: up to 39 weeks of gestation
Time to Discontinuation of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy
Time frame: up to 39 weeks of gestation
Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
Time frame: up to 39 weeks of gestation
Time to Start Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy
Time frame: up to 39 weeks of gestation
Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth
Time frame: up to end of study (4 months)
Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth
Time frame: up to end of study (4 months)
Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy
Time frame: up to end of study (4 months)
Time to Start Another MS Therapy During/After Pregnancy in Relation to Birth
Time frame: up to end of study (4 months)
Percentage of Women Using Other Therapies During Pregnancy
Time frame: up to 39 weeks of gestation
Percentage of Multiple Sclerosis Relapses in Women with Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Before, During and After Pregnancy
Time frame: up to end of study (4 months)
Change From Baseline Expanded Disability Status Scale (EDSS) During and After Pregnancy to Expanded Disability Status Scale (EDSS) Before Pregnancy
EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS). Scores range from 0.0 (normal) to 10.0 (death due to MS).
Time frame: Week 0 up to Week 39 of gestation
Number of Women Breastfeeding Under Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy
Time frame: up to end of study (4 months)
Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding
Time frame: up to end of study (4 months)
Time to First Multiple Sclerosis (MS) Relapse After Introduction of the First Supplemental Feedings in Women With Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Lactation
Time frame: up to end of study (4 months)
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