Prospective Registry of Exposure to Gepotidacin (PREG)

• None (Observational study) (Other), also known as Observational Study: Not Applicable since Observational Study
• None (Observational study) (Other), also known as Observational Study: Not Applicable since Observational Study

Primary outcomes

• Number of infants with major congenital malformations (MCMs) [At pregnancy outcome, with follow-up through 12 months after delivery]: 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.
• Number of infants with small-for-gestational-age births (SGA) [At live birth]: 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.

Secondary outcomes

• Number of infants with minor congenital malformations [At live Birth, with follow-up up through 12 months of age]: 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.
• Number of participants (pregnant women) with pregnancy termination [From date of conception (DOC) to <20 gestational weeks]: 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.
• Number of participants (pregnant women) with spontaneous abortions (SAB) [From date of conception (DOC) to <20 gestational weeks]: An involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks.
• Number of participants (pregnant women) with stillbirths [From 20 weeks' gestation to pregnancy outcome]: 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.
• Number of participants (pregnant women) with preeclampsia [From 20 weeks' gestation to pregnancy outcome]: 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
• Number of participants (pregnant women) with eclampsia [From 20 weeks' gestation to pregnancy outcome]: 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.
• Number of participants (pregnant women) with gestational hypertension [From 20 weeks' gestation to pregnancy outcome]: 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.
• Number of participants (pregnant women) with gestational diabetes [At pregnancy outcome]: Any degree of glucose intolerance with onset or first recognition during pregnancy.
• Number of participants (pregnant women) with preterm births [At live birth, if occurring before 37 gestational weeks]: Preterm birth is defined as a live birth occurring at <37 gestational weeks.
• Number of infants with postnatal growth deficiency [At 4 and 12 months of infant age]: Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts
• Number of infants with developmental delay [At 4 and 12 months of infant age]: Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention.

Sex: Female, ages: 15 Years to 50 Years

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

• GSK Clinical Trials, Study director, GlaxoSmithKline