The Penbraya Pregnancy Registry

What is a registry and why is it important?

A pregnancy registry is a study that collects health information from women who use prescription medicines or vaccines when they are pregnant. Information is also collected on the newborn baby.

Who is eligible to participate?

Patients may be eligible if they are:

  • Are resident of the United States
  • Are 10 through 25 years old
  • Are currently pregnant or have you been pregnant in the past year
  • Have been vaccinated with Penbraya™ during pregnancy or just prior to pregnancy (within 30 days prior to last menstrual period)

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

Contact card icon

Complete the consent to contact card here and a registry team member will contact them

Email the registry team at:

Telephone icon

Call the registry team toll-free at
1-877-390-2953 (hours of operation 8.30am - 5.00pm EST Monday-Friday)

Meningococcal infection affects an estimated 1.2 million individuals and causes 135,000 deaths per year, worldwide (Rouphael 2012).

Since pregnant individuals are excluded from clinical trial participation, there is limited data on the safety of vaccines for the prevention of meningococcal infection during pregnancy.

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the free registry app, via the website portal, or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctors’ visits or additional testing
  • No changes to patients’ medications or care

Eligible patients and their healthcare providers will receive compensation for providing data to the registry.

As the patient’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information

  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Infant growth and development information
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations.

Healthcare providers will be compensated when they submit data to the registry.

Eligible patients will be asked to provide information to the registry at enrollment, including basic demographic information (e.g., race, ethnicity, education), height and weight.

Thank you for your support in recruiting potential participants.

References

Rouphael NG, Stephens DS. Neisseria meningitidis: biology, microbiology, and epidemiology. Methods Mol Biol. 2012;799:1-20. doi: 10.1007/978-1-61779-346-2_1. PMID: 21993636; PMCID: PMC4349422

Register