Page:V-safe Pregnancy Registry Protocol, Version 2.pdf/4

v-safe pregnancy registry protocol: March 18, 2021, version 2 The population of pregnant persons eligible for surveillance through the pregnancy registry will include those exposed to COVID-19 vaccines during pregnancy or in the periconception period (30 days before LMP through 14 days after LMP) (Figure 1). Additional data will be collected on these pregnant persons; infants born to these persons will be monitored for the first three months of life to identify any newborn complications and diagnoses of major birth defects. Persons who are found not to be pregnant at the time of vaccination and are not identified as pregnant within 30 days after vaccination will not be included in the registry.

Identification of exposed pregnancies

V-safe is an opt-in text messaging and web-based surveillance system that will be offered to COVID-19 vaccine recipients. As part of the initial v-safe survey, all non-male participants (i.e., female, prefer not to say, other) will be asked questions about pregnancy status. In addition, screening questions to identify potential pregnancies will be asked at v-safe health check-ins that occur at days 21 and 42 after each vaccine dose (if applicable) and at 3, 6, and 12 months after the last vaccine dose (Figure 2). V-safe data managers at CDC will notify the pregnancy call center team (described below) of potential pregnant vaccine recipients daily. The pregnancy call center will be staffed by individuals trained to administer the questionnaire and also trained on the handling of PII. In order to identify as many pregnant persons as possible through v-safe, the follow up plan is:


 * If a person answers "yes" to any pregnancy question, on the v-safe text messaging survey, she will be sent a follow-up survey by Oracle to respond to three questions. The first question is confirming pregnancy and the other two questions are related to interest in participating in the registry. All survey responses will be sent to the pregnancy call center.
 * Those who responded “yes” to any pregnancy question, “yes” to being interested in being from the follow-up survey or who did not respond at all will be contacted by the pregnancy call center. During her initial call, she will be asked to participate in the pregnancy registry. If she declines, there will be no further contact by the pregnancy call center. She will remain enrolled in the v-safe text message monitoring system unless she elects to opt out.
 * If she no longer participates in the v-safe survey questions (i.e., stops responding or opts out) after indicating “don’t know” to a pregnancy question, she will also be contacted by the pregnancy call center within 3 months of her last response to inquire about her pregnancy status.

The CDC v-safe pregnancy call center staff will be notified of participants who may be pregnant via a dataset that will be created from the v-safe survey system. The dataset will include the following variables:


 * Unique v-safe id
 * First Name
 * Last Name
 * Sex
 * Full date of birth
 * Phone Number
 * Zip code