[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658353":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":57,"studyPopulation":61,"armGroups":62,"interventions":72,"overallOfficials":83,"centralContacts":87,"locations":57,"responsibleParty":96,"collaborators":98,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":57,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":57,"studyType":115,"phases":57,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":127,"whyStopped":57,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":57},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":57},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":16},"Number of infants with small-for-gestational-age births (SGA)","A newborn infant whose birth weight is less than (\\\u003C) 10th percentile for sex and gestational age using standard growth charts for full- and preterm live-born infants.","At live birth",[18,22,26,29,33,36,39,42,46,50,54],{"measure":19,"description":20,"timeFrame":21},"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",{"measure":23,"description":24,"timeFrame":25},"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 \u003C20 gestational weeks",{"measure":27,"description":28,"timeFrame":25},"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 (\\\u003C) 20 gestational weeks.",{"measure":30,"description":31,"timeFrame":32},"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",{"measure":34,"description":35,"timeFrame":32},"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 \\\u003C100,000\u002Fmilliliter (mL). Renal insufficiency: serum creatinine concentrations \\>1.1 milligram per deciliter (mg\u002FdL) 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",{"measure":37,"description":38,"timeFrame":32},"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.",{"measure":40,"description":41,"timeFrame":32},"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.",{"measure":43,"description":44,"timeFrame":45},"Number of participants (pregnant women) with gestational diabetes","Any degree of glucose intolerance with onset or first recognition during pregnancy.","At pregnancy outcome",{"measure":47,"description":48,"timeFrame":49},"Number of participants (pregnant women) with preterm births","Preterm birth is defined as a live birth occurring at \\\u003C37 gestational weeks.","At live birth, if occurring before 37 gestational weeks",{"measure":51,"description":52,"timeFrame":53},"Number of infants with postnatal growth deficiency","Weight, length, or head circumference in \\\u003C10th percentile for sex and chronological age using standard growth charts","At 4 and 12 months of infant age",{"measure":55,"description":56,"timeFrame":53},"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.",null,{"allocation":57,"interventionModel":57,"interventionModelDescription":57,"primaryPurpose":57,"observationalModel":59,"timePerspective":60,"maskingInfo":57},"COHORT","PROSPECTIVE","Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.",[63,68],{"label":64,"type":57,"description":65,"interventionNames":66},"Exposed cohort","Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window",[67],"Other: None (Observational study)",{"label":69,"type":57,"description":70,"interventionNames":71},"Comparator cohort","Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to standard-of-care antibiotics during the relevant exposure window",[67],[73,80],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"OTHER","None (Observational study)","Not Applicable since Observational Study",[64],[79],"Observational Study",{"type":74,"name":75,"description":76,"armGroupLabels":81,"otherNames":82},[69],[79],[84],{"name":85,"affiliation":5,"role":86},"GSK Clinical Trials","STUDY_DIRECTOR",[88,93],{"name":89,"role":90,"phone":91,"phoneExt":57,"email":92},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":94,"role":90,"phone":95,"phoneExt":57,"email":92},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":97,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR",[99],{"name":100,"class":101},"PPD Observational Studies (part of Thermo Fisher Scientific, Inc.)","UNKNOWN","100658353","prospective-registry-of-exposure-to-gepotidacin-preg-100658353",false,"NCT07850141","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","Inclusion Criteria:\n\nFor Both cohorts:\n\n* Participants with aged 15 to 50 years\n* United States resident\n* Currently pregnant\n* 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\n* Authorization and contact information for the reporter (e.g., participant, maternal\u002Finfant Health care provider (HCP), prescriber) to allow for follow-up\n\nExposed cohort:\n\n• Exposed to gepotidacin at any time during pregnancy or the relevant exposure window\n\nComparator cohort:\n\n* Diagnosis of and treatment for uUTI at any time during pregnancy or the relevant comparator product exposure window\n* 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\n\nExclusion Criteria:\n\nFor Both cohorts:\n\n• Diagnosis of known MCMs for the index pregnancy prior to enrollment\n\nExposed cohort:\n\n• None\n\nComparator cohort:\n\n• Exposure to gepotidacin at the time of enrollment","FEMALE","15 Years","50 Years",{"count":113,"type":114},614,"ESTIMATED","OBSERVATIONAL","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.",[118],"Sexually Transmitted Diseases",[120,121,122,123,124,125,126],"Observational","Cohort","Gepotidacin","Urinary tract infections","Neonatal","Maternal","Pregnancy","NOT_YET_RECRUITING","2026-09-29",{"date":130,"type":131},"2026-09-30","ACTUAL",{"date":130,"type":114},{"date":134,"type":114},"2032-08-19",{"name":5,"class":6}]