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Prospective Registry of Exposure to Gepotidacin (PREG)
Sponsor: GlaxoSmithKline
Summary
The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital malformations (MCMs) and small for gestational age (SGA), as well as to evaluate secondary maternal, fetal, and infant outcomes.
Official title: Prospective Registry of Exposure to Gepotidacin (PREG): a Prospective Registry of Women and Their Offspring Exposed to Gepotidacin During Pregnancy
Key Details
Gender
FEMALE
Age Range
15 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
614
Start Date
2026-09-30
Completion Date
2032-08-19
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
None (Observational study)
Not Applicable since Observational Study
None (Observational study)
Not Applicable since Observational Study