Page:V-safe Pregnancy Registry Protocol, Version 2.pdf/5

v-safe pregnancy registry protocol: March 18, 2021, version 2 * Time zone
 * Preferred language
 * Race/ethnicity
 * Vaccination dates
 * Vaccine type
 * Pregnancy response date
 * Survey number that identified pregnancy

Data collection

CDC v-safe pregnancy call center and registry

The CDC v-safe pregnancy call center (referred to in this protocol amendment as call center) will be operated by CDC staff from ISO and other groups at CDC with obstetric and pediatric expertise (including the COVID-19 Epidemiology & Surveillance Task Force Pregnancy and Infant Linked Outcomes Team, which includes clinicians from the Division of Reproductive Health and the Division of Birth Defects and Infant Disorders). The call center staff will contact persons identified as pregnant or potentially pregnant in v-safe by calling or texting them using the mobile phone number provided during v-safe registration. The call center staff will be trained to conduct phone interviews with the pregnant participants, including: confirmation of the identity of the v-safe participant and whether the person was pregnant at the time of vaccination or within 30 days after vaccination, informing the pregnant person about the pregnancy registry, including risks, benefits, and alternatives, requesting consent for participation in the registry and for release of medical records from healthcare providers, and asking specific survey questions relevant to pregnancy. The call center staff will also be trained on how to handle challenging situations, such as pregnancy loss, neonatal or infant death, diagnosis of major birth defects and other severe outcomes and when to defer a call to one of the call center clinicians. Persons will be contacted once each trimester during pregnancy and at two time points in the postpartum period, once after delivery and once after the infant is 3 months old. Information collected from the v-safe pregnancy call center survey and medical records will include demographics, pre-pregnancy and gestational conditions, pregnancy history, COVID-19 vaccine information, pregnancy complications, pregnancy outcome and infant outcomes.

The initial contact will collect pregnancy history information, including outcomes of prior pregnancies, dating of current pregnancy, and pregnancy complications or comorbidities to date. Subsequent brief call center follow ups will occur once every trimester to identify any pregnancy complications. A longer call center follow up will occur at 4-8 weeks postpartum to obtain information on the delivery and any potential complications in the mother or infant. At this postpartum contact, the call center will also request consent from the person for release of her infant’s medical records. A brief, final call center follow up will occur when the infant is 3 months old to inquire about any adverse events, including the diagnosis of any birth defects.

The call center staff will attempt to obtain medical records on all pregnant persons after the pregnancy conclusion (including medical records from obstetrical visits, ultrasounds, inpatient encounters, emergency room visits and notes from the delivery admission) and after the first 3 months of the infant’s life (including well visits, genetic testing, subspecialty encounters, inpatient encounters) for all participants who consent to medical