Prospective Registry of Exposure to Gepotidacin (PREG)

Prospective Registry of Exposure to Gepotidacin (PREG): a Prospective Registry of Women and Their Offspring Exposed to Gepotidacin During Pregnancy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexually Transmitted Diseases
• Intervention / Treatment: Other: None (Observational study)

• Study Type: Observational
• Enrollment (Estimated): 614

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed cohort; Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window	Other: None (Observational study); Not Applicable since Observational Study; Other Names: 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); Not Applicable since Observational Study; Other Names: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infants with minor congenital malformations	An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.	At live Birth, with follow-up up through 12 months of age
Number of participants (pregnant women) with pregnancy termination	A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or because of fetal abnormalities.	From date of conception (DOC) to <20 gestational weeks
Number of participants (pregnant women) with spontaneous abortions (SAB)	An involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks.	From date of conception (DOC) to <20 gestational weeks
Number of participants (pregnant women) with stillbirths	Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at greater than or equal to (>=) 20 weeks of gestation, or, if gestational age is unknown, a fetus weighing >=350 grams.	From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with preeclampsia	Preeclampsia is disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term, and proteinuria, or, in the absence of proteinuria, it is defined as new-onset hypertension with the new onset of any of the following: Thrombocytopenia: platelet count <100,000/milliliter (mL). Renal insufficiency: serum creatinine concentrations >1.1 milligram per deciliter (mg/dL) or a doubling of the serum creatinine concentration in the absence of other renal disease. Impaired liver function: elevated blood concentrations of liver transaminases to twice the normal concentration. Pulmonary edema. New-onset headache unresponsive to medication and not accounted for by alternative diagnoses or visual symptoms	From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with eclampsia	New-onset tonic-clonic, focal, or multifocal seizures in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use.	From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with gestational hypertension	Blood pressure greater than 140 millimeter of mercury (mmHg) systolic or 90 mmHg diastolic on 2 separate occasions at least 4 hours apart after 20 weeks of pregnancy when previous blood pressure was normal.	From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with gestational diabetes	Any degree of glucose intolerance with onset or first recognition during pregnancy.	At pregnancy outcome
Number of participants (pregnant women) with preterm births	Preterm birth is defined as a live birth occurring at <37 gestational weeks.	At live birth, if occurring before 37 gestational weeks
Number of infants with postnatal growth deficiency	Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts	At 4 and 12 months of infant age
Number of infants with developmental delay	Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention.	At 4 and 12 months of infant age

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: PPD Observational Studies (part of Thermo Fisher Scientific, Inc.)
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): August 19, 2032
• Study Completion (Estimated): August 19, 2032

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 29, 2026
• First Posted (Actual): September 30, 2026

Study Record Updates

• Last Update Posted (Actual): September 30, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Observational; Cohort; Maternal; Neonatal; Urinary tract infections; Gepotidacin
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Communicable Diseases; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Urinary Tract Infections; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 300392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No