Last updated: 09/11/2026 11:10:43

Prospective Registry of Exposure to Gepotidacin (PREG)

GSK study ID
300392
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Prospective Registry of Exposure to Gepotidacin (PREG): a prospective registry of women and their offspring exposed to gepotidacin during pregnancy
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of infants with major congenital malformations (MCMs)

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

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

Timeframe: At live birth

Secondary outcomes:

Number of infants with minor congenital malformations

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

Number of participants (pregnant women) with pregnancy termination

Timeframe: From date of conception (DOC) to pregnancy outcome

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

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

Number of participants (pregnant women) with stillbirths

Timeframe: From 20 weeks’ gestation to pregnancy outcome

Number of participants (pregnant women) with preeclampsia

Timeframe: From 20 weeks’ gestation to pregnancy outcome

Number of participants (pregnant women) with eclampsia

Timeframe: From 20 weeks’ gestation to pregnancy outcome

Number of participants (pregnant women) with gestational hypertension

Timeframe: From 20 weeks’ gestation to pregnancy outcome

Number of participants (pregnant women) with gestational diabetes

Timeframe: At pregnancy outcome

Number of participants (pregnant women) with preterm births

Timeframe: At live birth, if occurring before 37 gestational weeks

Number of infants with postnatal growth deficiency

Timeframe: At 4 and 12 months of infant age

Number of infants with developmental delay

Timeframe: At 4 and 12 months of infant age

Interventions:
Other: None (Observational study)
Enrollment:
614
Observational study model:
Cohort
Primary completion date:
2032-19-08
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Sexually Transmitted Diseases
Product
Not applicable
Collaborators
PPD Observational Studies (part of Thermo Fisher Scientific, Inc.)
Study date(s)
September 2026 to August 2032
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female
Age
15 - 50 Years
Accepts healthy volunteers
No
  • For Both cohorts:
  • Participants with aged 15 to 50 years
  • For Both cohorts:
  • Diagnosis of known MCMs for the index pregnancy prior to enrollment
Inclusion and exclusion criteria
Inclusion criteria:

    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
Exclusion criteria:

    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

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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