- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: US GSK Clinical Trials Call Center
- Numéro de téléphone: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
Sauvegarde des contacts de l'étude
- Nom: EU GSK Clinical Trials Call Center
- Numéro de téléphone: +44 (0) 20 89904466
- E-mail: GSKClinicalSupportHD@gsk.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
Autres noms:
|
|
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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of infants with major congenital malformations (MCMs)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of infants with minor congenital malformations
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: GSK Clinical Trials, GlaxoSmithKline
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Attributs de la maladie
- Infections
- Maladies transmissibles
- Conditions pathologiques, signes et symptômes
- Maladies sexuellement transmissibles
- Infections des voies urinaires
- Techniques d'investigation
- Méthodes
- Observation
Autres numéros d'identification d'étude
- 300392
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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