Prospective Registry of Exposure to Gepotidacin (PREG)
ConditionSexually Transmitted Diseases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-50
SponsorGlaxoSmithKline
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
None (Observational study)
Other interventionNot Applicable since Observational Study
None (Observational study)
Other interventionNot Applicable since Observational Study
Treatment groups
614 Participants
are divided into 2 treatment groupsGroup A: Exposed cohort1 intervention
Group B: Comparator cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At pregnancy outcome, with follow-up through 12 months after delivery2
Number of infants with small-for-gestational-age births (SGA)
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.
Time frame
At live birthSecondary outcomes
1
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.
Time frame
At live Birth, with follow-up up through 12 months of age2
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.
Time frame
From date of conception (DOC) to <20 gestational weeks3
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 (\<) 20 gestational weeks.
Time frame
From date of conception (DOC) to <20 gestational weeks4
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.
Time frame
From 20 weeks' gestation to pregnancy outcomeLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
GlaxoSmithKline
Lead sponsor
PPD Observational Studies (part of Thermo Fisher Scientific, Inc.)
Collaborator
Source ClinicalTrials.gov
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