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NOT YET RECRUITING
NCT07850141

Prospective Registry of Exposure to Gepotidacin (PREG)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

Interventions

OTHER

None (Observational study)

Not Applicable since Observational Study

OTHER

None (Observational study)

Not Applicable since Observational Study