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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: US GSK Clinical Trials Call Center
- Numero di telefono: 877-379-3718
- Email: GSKClinicalSupportHD@gsk.com
Backup dei contatti dello studio
- Nome: EU GSK Clinical Trials Call Center
- Numero di telefono: +44 (0) 20 89904466
- Email: GSKClinicalSupportHD@gsk.com
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Exposed cohort
Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window |
Not Applicable since Observational Study
Altri nomi:
|
|
Comparator cohort
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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of infants with major congenital malformations (MCMs)
Lasso di tempo: 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. |
At pregnancy outcome, with follow-up through 12 months after delivery
|
|
Number of infants with small-for-gestational-age births (SGA)
Lasso di tempo: 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. |
At live birth
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of infants with minor congenital malformations
Lasso di tempo: 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. |
At live Birth, with follow-up up through 12 months of age
|
|
Number of participants (pregnant women) with pregnancy termination
Lasso di tempo: 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. |
From date of conception (DOC) to <20 gestational weeks
|
|
Number of participants (pregnant women) with spontaneous abortions (SAB)
Lasso di tempo: 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. |
From date of conception (DOC) to <20 gestational weeks
|
|
Number of participants (pregnant women) with stillbirths
Lasso di tempo: 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. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with preeclampsia
Lasso di tempo: 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 |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with eclampsia
Lasso di tempo: 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. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with gestational hypertension
Lasso di tempo: 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. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with gestational diabetes
Lasso di tempo: At pregnancy outcome
|
Any degree of glucose intolerance with onset or first recognition during pregnancy. |
At pregnancy outcome
|
|
Number of participants (pregnant women) with preterm births
Lasso di tempo: At live birth, if occurring before 37 gestational weeks
|
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
Lasso di tempo: 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 |
At 4 and 12 months of infant age
|
|
Number of infants with developmental delay
Lasso di tempo: 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. |
At 4 and 12 months of infant age
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Direttore dello studio: GSK Clinical Trials, GlaxoSmithKline
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Processi patologici
- Malattie urogenitali maschili
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Attributi della malattia
- Infezioni
- Malattie trasmissibili
- Condizioni patologiche, segni e sintomi
- Malattie trasmesse sessualmente
- Infezioni del tratto urinario
- Tecniche investigative
- Metodi
- Osservazione
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 300392
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