At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with migraine
- ✓History of migraine pre-pregnancy with average of at least 4 migraine days per month in the 6 months before last menstrual period (LMP)
- ✓Last menstrual period between November 1st, 2019 and March 31st, 2021
- ✓Age 18-42 years at first day of last menstrual period of study pregnancy
- ✕History of preterm birth (gestational age <37 weeks) in previous pregnancies prior to study pregnancy
- ✕History of congenital malformations or birth defects in previous pregnancies prior to study pregnancy
- ✕Severe diseases that started before and persisted into study pregnancy: congenital heart disease, arrhythmia, prior myocardial infarction, prior stroke, or active cancer
- ✕Serious physical injury during study pregnancy (e.g., severe car collision, serious home/work injury)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum
In Brief
An observational study evaluating Nerivio and Migraine Relief for Migraine and Pregnancy Related. Completed, enrolled 145 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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
Any drug for treatment of migraine relief