Prospective Registry of Exposure to Gepotidacin (PREG)

NCT07850141 | Not Yet Recruiting FDA Drug

• 1 other identifier: 300392
• Study Type: observational
• Target: 614
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sexually Transmitted Diseases

Keywords

Observational; Cohort; Gepotidacin; Urinary tract infections; Neonatal; Maternal; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Number of infants with major congenital malformations (MCMs)

  An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.

  At pregnancy outcome, with follow-up through 12 months after delivery

• Number of infants with small-for-gestational-age births (SGA)

  A newborn infant whose birth weight is less than (\<) 10th percentile for sex and gestational age using standard growth charts for full- and preterm live-born infants.

  At live birth

Secondary Outcomes (11)

• Number of infants with minor congenital malformations

  At live Birth, with follow-up up through 12 months of age

• Number of participants (pregnant women) with pregnancy termination

  From date of conception (DOC) to <20 gestational weeks

• Number of participants (pregnant women) with spontaneous abortions (SAB)

  From date of conception (DOC) to <20 gestational weeks

• Number of participants (pregnant women) with stillbirths

  From 20 weeks' gestation to pregnancy outcome

• Number of participants (pregnant women) with preeclampsia

  From 20 weeks' gestation to pregnancy outcome

Study Arms (2)

Exposed cohort

Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window

Other: None (Observational study)

Comparator cohort

Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to standard-of-care antibiotics during the relevant exposure window

Other: None (Observational study)

Interventions

None (Observational study) OTHER

Not Applicable since Observational Study

Also known as: Observational Study

Exposed cohort

Eligibility Criteria

• Age: 15 Years - 50 Years
• Gender Eligibility Details: Pregnant
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.

You may qualify if:

• For Both cohorts:
• Participants with aged 15 to 50 years
• United States resident
• Currently pregnant
• Participants personally signed and dated informed consent document or, upon waiver of written consent by the relevant Institutional review board (IRB), verbal consent indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study
• Authorization and contact information for the reporter (e.g., participant, maternal/infant Health care provider (HCP), prescriber) to allow for follow-up
• Exposed cohort:
• Exposed to gepotidacin at any time during pregnancy or the relevant exposure window
• Comparator cohort:
• Diagnosis of and treatment for uUTI at any time during pregnancy or the relevant comparator product exposure window
• Exposed to one or more American College of Obstetricians and Gynecologists (ACOG)-recommended treatments for acute cystitis at any time during pregnancy or the relevant comparator product exposure window

You may not qualify if:

• For Both cohorts:
• Diagnosis of known MCMs for the index pregnancy prior to enrollment
• Exposed cohort:
• None
• Comparator cohort:
• Exposure to gepotidacin at the time of enrollment

Sponsors & Collaborators

• GlaxoSmithKline: lead
• PPD Observational Studies (part of Thermo Fisher Scientific, Inc.): collaborator

MeSH Terms

Conditions

Sexually Transmitted Diseases; Urinary Tract Infections

Interventions

Observation

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 30, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): August 19, 2032
• Study Completion (Estimated): August 19, 2032
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share