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Prospective Registry of Exposure to Gepotidacin (PREG)

29 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

614

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar tot 50 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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

Andere namen:
  • Observatie studie
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

Andere namen:
  • Observatie studie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of infants with major congenital malformations (MCMs)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of infants with minor congenital malformations
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Studie directeur: GSK Clinical Trials, GlaxoSmithKline

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 september 2026

Primaire voltooiing (Geschat)

19 augustus 2032

Studie voltooiing (Geschat)

19 augustus 2032

Studieregistratiedata

Eerst ingediend

11 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 september 2026

Eerst geplaatst (Werkelijk)

30 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

29 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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