Sexually Transmitted DiseasesNCT07850141
Prospective Registry of Exposure to Gepotidacin (PREG)
An observational study of Sexually Transmitted Diseases, run by GlaxoSmithKline.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- None (Observational study)
- How many people
- 614 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 19 Aug 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- None (Observational study)
- Keywords
- Observational, Cohort, Gepotidacin, Urinary tract infections, Neonatal, Maternal, Pregnancy
- Medical subject headings
- Sexually Transmitted Diseases, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
Also called Observational Study
Not Applicable since Observational Study
None (Observational study)Other
Also called Observational Study
Not Applicable since Observational Study
| Study group | Role | What they receive |
|---|---|---|
| Exposed cohort | Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window Receives: Other: None (Observational study) | |
| Comparator cohort | Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to standard-of-care antibiotics during the relevant exposure window Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At pregnancy outcome, with follow-up through 12 months after delivery
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.
Measured: At live birth
Secondary outcomes (11)
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.
Measured: At live Birth, with follow-up up through 12 months of age
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.
Measured: From date of conception (DOC) to <20 gestational weeks
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.
Measured: From date of conception (DOC) to <20 gestational weeks
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.
Measured: From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with preeclampsia
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
Measured: From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with eclampsia
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.
Measured: From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with gestational hypertension
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.
Measured: From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with gestational diabetes
Any degree of glucose intolerance with onset or first recognition during pregnancy.
Measured: At pregnancy outcome
Number of participants (pregnant women) with preterm births
Preterm birth is defined as a live birth occurring at <37 gestational weeks.
Measured: At live birth, if occurring before 37 gestational weeks
Number of infants with postnatal growth deficiency
Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts
Measured: At 4 and 12 months of infant age
Number of infants with developmental delay
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention.
Measured: At 4 and 12 months of infant age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion19 Aug 2032 (estimated)
- Study completion19 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Observational Studies (part of Thermo Fisher Scientific, Inc.)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850141
- Sponsor's protocol ID
- 300392
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No