BEXSERO® Pregnancy Registry
BEXSERO® pregnancy registry is established to evaluate the safety of BEXSERO when it is used during pregnancy. The registry will prospectively collect information on pregnant women who have been immunized with BEXSERO within 30 days prior to their last menstrual period or at any time during pregnancy. The objective of the BEXSERO Pregnancy Registry is to evaluate the outcomes of pregnancy, including major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be also be collected, including spontaneous abortions and stillbirths. This registry will not involve any special intervention or treatment and is strictly observational. Routine care will continue unchanged and the schedule of office visits and all treatment regimens will be determined by the treating health care provider (HCP).
The registry has multiple enrolment channels. An Eligible pregnant woman may self-enroll at any time during their pregnancy or, with their consent, their HCP may enroll them on their behalf. In addition, health maintenance organizations can report de-identified data on pregnancy exposures and outcomes. Information will be collected about the general health status of the pregnant woman and her baby during pregnancy and at delivery.
The registry population includes pregnant women within the United States (US) who were immunized with the BEXSERO vaccine within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy.
The minimum criteria required for enrollment into the registry are as follows:
For more information please contact PPD via the information below:
Estimated Enrollment: 50