This will be a prospective research registry from which retrospective research studies
will derive. Individuals who are eligible to participate in the CEFALY Pregnancy Registry
will be pregnant women who have migraines or headaches. Use of the external Trigeminal
Neurostimulation (eTNS) device is not mandatory for participation in the registry, and
the registry will include information from individuals who use and do not use eTNS
(CEFALY) to treat their migraines or headaches before, during, and after pregnancy.
The ideal candidate for participation will be women within 14 weeks gestation at the time
of screening enrollment, as this will minimize any recall bias. However, women in the
second and third trimesters during screening and enrollment will not be excluded and may
also participate in the registry. The registry will aim to enroll 550 participants per
the inclusion and exclusion criteria.
Registry participation, including consent, screening, enrollment, and completion of
registry surveys, will be completed online using a confidential survey platform accessed
via a publicly available web-based link. Once the simple consent is acknowledged, the
potential participant will enter their name, email, phone number and date of birth. The
phone number, and email entered are required to conduct the registry data collection
process.
Participants will then complete screening questions to assess their eligibility for the
registry. If they meet all eligibility requirements, they will be required to upload
sufficient evidence of a current intrauterine pregnancy. The registry investigators will
verify the uploaded document for accuracy before enrollment. The participant's name and
date of birth are required to validate a current pregnancy based on the required uploaded
documents during the screening process.
If eligible and documentation of current pregnancy is confirmed, the investigators will
enroll the participant in the registry and start the survey process. Enrolled
participants who have agreed to participate in the registry will receive an invitation to
the requested surveys via automated email and short message service (SMS) text. The links
provided in the email and SMS text will automatically direct the participant to the
appropriate survey based on the timing of their enrollment, estimated due date, pregnancy
status, and date of completion of prior surveys. Before each survey attempt, enrolled
participants will need to verify their identity with an automated authentication code
provided to their registered email address and phone number they provided during initial
screening to verify their data and protect their entered health information.
In general, the surveys will ask questions about the participant's health history, their
previous pregnancies (if applicable), current pregnancy, migraine or headache symptoms
and migraine treatments and therapies. In addition, participants will be asked to
complete several validated scales assessing the degree of migraine disability and mental
health impact. If the participant indicates that they are using eTNS CEFALY during the
registry process, they will also receive surveys about their eTNS use. Any unclear survey
responses are found during periodic reviews as part of data quality assurance. In that
case, study staff may contact the participant via email and/or phone call to clarify an
answer or answers on the survey.
In most circumstances, the registry participants will be asked to complete up to six
surveys. Based on preliminary registry testing, the enrollment (consent and screening)
and baseline period will take participants approximately 20 minutes to complete. The five
sets of surveys (1st, 2nd, 3rd trimester, early postpartum, and late postpartum) will
take approximately 10 - 15 minutes for each participant to complete. Therefore, we
estimate that the total participation time for most participants will be between 60 and
90 minutes. In some situations, the timing and number of surveys and time points
requested will differ for some participants based on their responses.
A link to a survey will be sent to the participant's email and phone via text for each of
the following time points as indicated by the patient's estimated due date at time of
enrollment.
Pre-pregnancy and Baseline: This survey will be sent following registry enrollment First
trimester: This survey will be sent at 14 weeks gestation Second trimester: This survey
will be sent at 28 weeks gestation Third trimester: This survey will be sent at 37 weeks
gestation. Early postpartum: This survey will be sent 6 weeks following childbirth Late
postpartum: This survey will be sent 12 weeks following childbirth
If the participant enrolls in the registry beyond any of the gestation periods described
above, they will also be asked to complete the baseline and earlier trimester surveys
before their current trimester following registry enrollment. If the participant delivers
before 37 weeks gestation, the third-trimester survey will be sent following notification
of childbirth.