An observational study in Pregnancy, Obesity and Overweight, sponsored by Novo Nordisk A/S. Enrolling by invitation at 3 sites in 3 countries. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Novo Nordisk A/S · Observational
This is an observational, prospective Wegovy (semaglutide 2.4 milligram [mg]) Pregnancy Registry Study. The aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to Wegovy during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition with outcomes in an internal comparison cohort of pregnant women with obesity or overweight with at least one weight related comorbid condition at conception and who are not exposed to Wegovy or other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) during pregnancy. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 728 is above the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant participants exposed to Wegovy during pregnancy, and pregnant participants who were not exposed to Wegovy or other GLP-1 RAs at any time during pregnancy but who may be exposed to other products for weight management with obesity and overweight were to be observed prospectively.
Exclusion Criteria:
Pregnant women who are exposed to Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition will be observed in this prospective observational study.
Other: No Intervention
Pregnant women who have overweight with at least one weight-related comorbid condition or who have obesity at conception and who are not exposed to Wegovy or other GLP-1 RAs at any time during pregnancy but who may be exposed to other products for weight management will be observed in this prospective observational study.
Other: No Intervention
This is a non-interventional study, therefore no intervention is used.
Number of Infants with Major Congenital Malformation (MCM)
Number of infants with MCM is defined as an abnormality of body structure or function that is present at birth; is of prenatal origin (that is, birth defect); has significant medical, social, or cosmetic consequences for the affected individual; and typically requires medical intervention.
Time frame: From date of conception (DOC) to pregnancy outcome for foetal losses or 12 months of infant age for live births
Number of Infants with Minor Congenital Malformation
Number of infants with minor congenital malformation is defined as an anomaly or abnormality of body structure that is present at birth, is of prenatal origin (that is, 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: From DOC to pregnancy outcome for foetal losses or 12 months of infant age for live births
Number of Pregnant Participants With Pre-eclampsia
Number of pregnant participants with pre-eclampsia is defined as pregnant participants with high blood pressure and signs of liver or kidney damage occurring at greater than (\>) 20 gestational weeks through 6 weeks postpartum.
Time frame: From 20 0/7 gestational weeks to 6 weeks
Number of Pregnant Participants With Eclampsia
Eclampsia is defined as seizures or coma in a woman with pre-eclampsia during pregnancy through 6 weeks postpartum.
Time frame: From 20 0/7 gestational weeks to 6 weeks
Number of Pregnant Participants Experiencing Spontaneous Abortion
Number of pregnant participants experiencing spontaneous abortion is defined as an involuntary foetal loss or the expulsion of the products of conception occurring at less than (\<) 20 gestational weeks.
Time frame: From date of conception to 19 6/7 gestational weeks
Number of Pregnant Participants Experiencing Stillbirth
Number of pregnant participants experiencing still birth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary foetal loss occurring at greater than or equal to (\>=)20 gestational weeks or, if gestational age is unknown, a foetus weighing \>=350 gram.
Time frame: From 20 0/7 gestational weeks to pregnancy outcome (week 40)
Number of Pregnant Participants With Elective Termination
Number of pregnant participants with elective termination is defined as a voluntary foetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to foetal abnormalities.
Time frame: From date of conception to pregnancy outcome (week 40)
Number of Pregnant Participants With Preterm Delivery
Preterm birth is defined as a live birth occurring at \<37 gestational weeks.
Time frame: From date of conception to 37 gestational weeks (week 37)
Number of Infants Experiencing Small for Gestational Age (SGA) Birth
Number of infants experiencing small for gestational age is defined as weight at birth in \<10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Time frame: At delivery of live birth
Number of Infants With Postnatal Growth Deficiency
Number of infants with postnatal growth deficiency is defined as infants with weight, length, or head circumference in \<10th percentile for sex and age using standard growth charts.
Time frame: At 4 and 12 months of infant age
Number of infants with Developmental Delay
Infant development delay is defined as infants with failure to achieve the developmental milestones for age, as defined by the Centers for Disease Control and Prevention (CDC).
Time frame: At 4 and 12 months of infant age
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on NovoNordisk-trials.com
No publications or documents are linked to this record.
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Novo Nordisk A/S