BlujepaŽ (gepotidacin) Pregnancy Registry

The PREG (Prospective Registry of Exposure to Gepotidacin) Pregnancy Registry is a non-interventional, observational study for individuals who are pregnant or were recently pregnant and were exposed to BlujepaŽ (gepotidacin) for a urinary tract infection (UTI), another health condition, or an unknown reason. The registry also includes individuals who had a UTI during pregnancy and were treated with another antibiotic.

The registry collects information about pregnancy and infant health outcomes in real-world settings, with infant health information collected up to one year of age. Information is collected from participants and the healthcare providers involved in their care or their babies' care. Taking part will not change your medical care or treatment and will not involve any additional clinical procedures beyond routine care.

Eligibility Criteria:

• Are a resident of the United States
• Aged 15 to 50 years
• Currently pregnant or recently pregnant and have
• Been diagnosed with uncomplicated urinary tract infection (uUTI)
OR

• Taken BlujepaŽ (gepotidacin) during pregnancy or just prior to pregnancy (within one week prior to conception)
OR

• Taken specific medications to treat uUTI
• You (and/or your parent/legal representative) provide consent to participate and agree to the study requirements, including the interview schedule and release of medical records.

What can I expect if I participate:

If you are eligible and would like to participate, you will be asked to:

1. Provide your consent (a requirement for participation in any research study)
2. Give the registry permission to contact your healthcare provider(s) to collect information for the study

You and your healthcare provider(s) will provide information to the registry about your pregnancy and your baby's health up to 1 year of age. This information can be provided by completing paper forms or via short phone interviews with one of the registry staff members. Only information normally documented in your medical record will be collected.

Participation is voluntary and patients may withdraw from registry any time without affecting their medical care.

• No extra doctor's visits or additional testing
• No changes to your existing healthcare provider(s) or care
• You and your healthcare provider(s) will receive compensation for providing data to the registry

If you are eligible and would like to participate, you will be asked to provide information to the registry at enrollment and may provide additional information periodically throughout your pregnancy:

• At enrollment, you will be asked to provide basic information about yourself (e.g., race, ethnicity, education, height, and weight) and information about your history of uUTIs.
• Throughout pregnancy, specifically at the end of the second trimester, shortly after birth, and at 4 and 12 months after a live birth, you may be asked to provide additional information about your pregnancy and your baby.

Contact Information:

The study is conducted on behalf of GSK by PPD.

PPD
929 N. Front Street
Wilmington, NC 28401

Evidera, a PPD business unit
3900 Paramount Parkway
Morrisville, NC 27560

Registry Toll-Free Telephone:

1-877-371-0315 (hours of operation 8:30 am -5:00 pm EST Monday-Friday)

Email: PREGpregnancyregistry@thermofisher.com

Additional Resources:

Link to prescribing information for Blujepa Pregnancy Registry