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Prospective Registry of Exposure to Gepotidacin (PREG)

29 septembre 2026 mis à jour par: GlaxoSmithKline

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

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

614

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

15 ans à 50 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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:
  • Étude observationnelle
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:
  • Étude observationnelle

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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Collaborateurs

Les enquêteurs

  • Directeur d'études: GSK Clinical Trials, GlaxoSmithKline

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 septembre 2026

Achèvement primaire (Estimé)

19 août 2032

Achèvement de l'étude (Estimé)

19 août 2032

Dates d'inscription aux études

Première soumission

11 septembre 2026

Première soumission répondant aux critères de contrôle qualité

29 septembre 2026

Première publication (Réel)

30 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

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) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .