Migraine, Pregnancy Related
Conditions
Brief 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)
Interventions
DEVICENerivio
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
DRUGMigraine Relief
Any drug for treatment of migraine relief
Sponsors
Theranica
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosed with migraine 2. History of migraine pre-pregnancy with an average of at least 4 migraine days per month, in the six months prior to the last pregnancy 3. History of pregnancy with last menstrual period (LMP) between November 1st, 2019 - March 31st, 2021. Pregnancy within this time window is the pregnancy of study, termed study pregnancy 4. Between 18 and 42 years of age at first day of the last menstrual period (LMP) of study pregnancy 5. History of at least 4 migraine attacks during study pregnancy 6. In the study group: usage of Nerivio for at least 3 treatments (≥30 minutes/treatment) during study pregnancy 7. In the control group: No history of using Nerivio, ever
Exclusion criteria
1. History of preterm birth (gestational age at deliver\<37 weeks) in previous pregnancies prior to the study pregnancy 2. History of congenital malformations or birth defects in previous pregnancies prior to the study pregnancy 3. Severe other diseases which started before the study pregnancy and lasted into the study pregnancy period, including congenital heart disease, arrhythmia, history of myocardial infarction (MI), history of stroke, or active cancer 4. Serious physical injury that occurred during the study pregnancy: severe car collision injury, serious injury at home/work, etc. Multiple gestation (i.e., pregnancy with more than one baby at a time, such as pregnancy with twins, triplets, and quadruplets) in the study pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Age at Delivery | Retrospective Data for up to 42 weeks, collected over 2 months | The mean number of gestational age at delivery in both study groups (measured in pregnancy days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage Rate | Retrospective Data for up to 42 weeks, collected over 2 months | The percent of miscarriage in both study groups |
| Preterm Birth Rate | Retrospective Data for up to 42 weeks, collected over 2 months | The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups |
| Birth Deficits Rate | Retrospective Data for up to 42 weeks, collected over 2 months | The percent of birth deficits in both study groups |
| Birth Weight | Retrospective Data for up to 42 weeks, collected over 2 months | The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds). |
| Developmental Milestones Rate Following 3 Months Postnatal | Retrospective Data for up to 55 weeks, collected over 2 months | The rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces) |
| Migraine Patterns | Retrospective Data for up to 55 weeks, collected over 2 months | The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups |
| Still Births Rate | Retrospective Data for up to 42 weeks, collected over 2 months | The percent of Still birth in both study groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
Nerivio: 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 | 59 |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. 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
Migraine Relief: Any drug for treatment of migraine relief | 81 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 2 |
Baseline characteristics
| Characteristic | Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Total |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 6.1 | 32.2 years STANDARD_DEVIATION 6 | 32.4 years STANDARD_DEVIATION 6.1 |
| Body Mass Index (BMI) | 26.8 Kg/m^2 STANDARD_DEVIATION 7.4 | 25.8 Kg/m^2 STANDARD_DEVIATION 6.1 | 26.2 Kg/m^2 STANDARD_DEVIATION 6.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White or Caucasian | 46 Participants | 70 Participants | 116 Participants |
| Sex: Female, Male Female | 59 Participants | 81 Participants | 140 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 81 |
| other Total, other adverse events | 0 / 59 | 0 / 81 |
| serious Total, serious adverse events | 0 / 59 | 0 / 81 |
Outcome results
Primary
Gestational Age at Delivery
The mean number of gestational age at delivery in both study groups (measured in pregnancy days).
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Gestational Age at Delivery | 271 Gestational days | Standard Deviation 13 |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Gestational Age at Delivery | 273 Gestational days | Standard Deviation 9 |
p-value: 0.16t-test, 2 sided
Secondary
Birth Deficits Rate
The percent of birth deficits in both study groups
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Birth Deficits Rate | 8 Participants |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Birth Deficits Rate | 11 Participants |
Secondary
Birth Weight
The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds).
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Birth Weight | 7.2 Weight (pounds) | Standard Deviation 1.2 |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Birth Weight | 7.2 Weight (pounds) | Standard Deviation 1 |
Secondary
Developmental Milestones Rate Following 3 Months Postnatal
The rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces)
Time frame: Retrospective Data for up to 55 weeks, collected over 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Developmental Milestones Rate Following 3 Months Postnatal | 57 Participants |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Developmental Milestones Rate Following 3 Months Postnatal | 77 Participants |
Secondary
Migraine Patterns
The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups
Time frame: Retrospective Data for up to 55 weeks, collected over 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Migraine Patterns | 9 Participants |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Migraine Patterns | 14 Participants |
Secondary
Miscarriage Rate
The percent of miscarriage in both study groups
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Miscarriage Rate | 2 Participants |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Miscarriage Rate | 3 Participants |
Secondary
Preterm Birth Rate
The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Preterm Birth Rate | 8 Participants |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Preterm Birth Rate | 5 Participants |
Secondary
Still Births Rate
The percent of Still birth in both study groups
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Still Births Rate | 0 Participants |
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Still Births Rate | 0 Participants |