Prospective Registry of Exposure to Gepotidacin (PREG)

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

Not Applicable since Observational Study

• Megfigyelési tanulmány

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

Not Applicable since Observational Study

• Megfigyelési tanulmány

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.

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.

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.

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.

An involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks.

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.

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

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.

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.

Any degree of glucose intolerance with onset or first recognition during pregnancy.

Preterm birth is defined as a live birth occurring at <37 gestational weeks.

Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts

Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention.