Safety of Nerivio in Pregnant Women With Migraine
Condition: Migraine; Pregnancy Related
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      This is a retrospective controlled survey study to assess the safety of treating migraine
      with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and
      pregnancy-related health and baby health between women with migraine who treated migraine
      attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not
      treat migraine attacks during pregnancy with Nerivio (control group). Nerivio group
      participants will be recruited from Theranica's user base. Control group participants will be
      recruited by health care providers, including headache specialists and OBGYNs (study
      co-investigators). The study is based on an e-Survey including an e-eligibility
      questionnaire, an e-ICF ande-Questionnaire. Participants will be compensated for their time.
    

Detailed description: 
      This is a retrospective controlled survey study to assess the safety of treating migraine
      with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and
      pregnancy-related health and baby health between women with migraine who treated migraine
      attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not
      treat migraine attacks during pregnancy with Nerivio (control group).

      Study group: Study group participants will be recruited from Nerivio's user base. An
      invitation message will be sent via in-app notification and/or email to all Nerivio users who
      are (1) female, AND (2) between 18 and 42 years of age as of November 1st, 2019 - March 31st,
      2021. Users who meet these criteria will be invited to fill in a screening and eligibility
      questionnaire. If they meet the eligibility criteria, they will be offered the opportunity to
      participate in the study. Participants will complete and sign an electronic informed consent
      form. Following consent, participants will be asked to complete the questionnaire. Once
      complete, participants will be compensated for their time.

      Control group: Control group participants will be referred to the study by site
      co-investigators, who are US-licensed healthcare providers seeing women with headache
      disorders and/or women during their pre-pregnancy and/or pregnancy period. Patients
      interested in participating will be directed to the same screening and eligibility
      questionnaire and will follow the same study design.

      Endpoints focus on the health of the mother and the baby, during pregnancy and three months
      postpartum.

      Primary endpoint:

      Demonstrate that the study group is not different than the control group in regard to
      gestational age at delivery (measured in pregnancy weeks).

      Secondary endpoints:

      Demonstrate that the study group is not different from the control group in:

        1. Baby's birth weight (average birth weight)

        2. Miscarriage rate (% of miscarriage cases)

        3. Preterm birth rate (% cases of preterm pregnancies, as measured in % of pregnancy weeks
           less than 37)

        4. Birth deficits rate (% of birth deficits)

        5. Still births rate (% of still births)

        6. Meeting developmental milestones following 3 months postnatal (% of babies)

        7. Visits to the emergency room or urgent care due to pregnancy and/or migraine symptoms
           during pregnancy and 3 months postpartum period (# of events)
    

Intervention name(s): Nerivio
Intervention type(s): Device
Intervention description(s): Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Post pregnant women between 18 and 42 years of age at first day of the last menstrual
        period (LMP) of "study pregnancy."