[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05503927":3,"trial-entities:NCT05503927":117,"trial-summary:NCT05503927":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":17,"eligibility_criteria":69,"std_ages":89,"locations":92,"central_contacts":110,"overall_officials":111,"references":115,"see_also_links":116},"NCT05503927","NN9536-4971","A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy","Wegovy® (Semaglutide) Database Study: A Population-based Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy","ENROLLING_BY_INVITATION","2027-08-15","2026-07","2026-07-21","2020-02-01","Novo Nordisk A\u002FS","INDUSTRY",true,"This is an observational cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.",null,[19,20,21],"Pregnancy","Obesity","Overweight",[],"OBSERVATIONAL",[],{"count":26,"type":27},2701,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"OTHER","No Intervention","This is a non-interventional study, therefore no intervention is used.",[34,35,36],"Overweight\u002FObese Participants","Participants Exposed to Anti-obesity Medication (AOM)","Participants Exposed to Wegovy injection or Wegovy tablet",[38],{"measure":39,"description":40,"timeFrame":41},"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.","Birth up to 1 year of age",[43,46,49,52,56,59,63],{"measure":44,"description":45,"timeFrame":41},"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 less than (\\\u003C) 10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.",{"measure":47,"description":48,"timeFrame":41},"Number of infants with Developmental Delay","Infant development delay will be defined as infants with evidence of one or more of the following outcomes in the first year of life: delayed milestone in childhood, other lack of normal physiological development, special screening for developmental disabilities.",{"measure":50,"description":51,"timeFrame":41},"Number of Infants With Postnatal Growth Deficiency","Number of infants with adverse postnatal growth will be defined as infants with evidence of the following outcomes in the first year of life: abnormal weight gain (insufficient or excessive weight gain), short stature, failure to thrive.",{"measure":53,"description":54,"timeFrame":55},"Number of Pregnant Participants Experiencing Stillbirth","Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (\\>=20) WGA.","up to 37 weeks of gestational age",{"measure":57,"description":58,"timeFrame":55},"Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)","Number of pregnant participants experiencing SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at \\\u003C20 WGA.",{"measure":60,"description":61,"timeFrame":62},"Number of Pregnant Participants With Preterm Delivery","Preterm birth is defined as a live birth occurring at \\\u003C37 WGA.","Up to 37 weeks of gestational age",{"measure":64,"description":65,"timeFrame":62},"Number of Pregnant Participants With Pre-eclampsia\u002Feclampsia","Pre-eclampsia\u002Feclampsia is defined as new onset of hypertension with proteinuria occurring at \\>=20WGA through the six weeks following pregnancy end.","FEMALE","15 Years","50 Years",{"inclusion":70,"exclusion":84,"raw_text":88},[71,72,73,74,75,76,77,78,79,80,81,82,83],"Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2034).","Date of conception between 04 June 2021 and 06 May 2033 (that is last menstrual period (LMP) 43 weeks prior to the latest pregnancy end date).","Aged 15-50 and female on the date of the LMP.","Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of conception through 42 days after the pregnancy end date.","Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated date of conception to end of pregnancy. Two mutually exclusive cohorts will be identified based on first Wegovy exposure during pregnancy.","Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion\u002Fnaltrexone exposure, defined as the following:","Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from one day prior to estimated conception date to end of pregnancy.","Phentermine or bupropion\u002Fnaltrexone exposure from five days prior to estimated conception date to end of pregnancy.","Cohort with Overweight\u002FObesity and at least one weight related comorbid condition-","Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg\u002Fm\\^2) on a medical claim during the six month pre-pregnancy period.","Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg\u002Fm\\^2 or less than 30 kg\u002Fm\\^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period.","No exposure to Wegovy or other AOM during the defined exposure window in pregnancy.","Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at less than 14 WGA.",[85,86,87],"Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (that is, 35 days prior to estimated conception date through pregnancy end date).","Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date).","Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.","Inclusion Criteria:\n\n* Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2034).\n* Date of conception between 04 June 2021 and 06 May 2033 (that is last menstrual period (LMP) 43 weeks prior to the latest pregnancy end date).\n* Aged 15-50 and female on the date of the LMP.\n* Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of conception through 42 days after the pregnancy end date.\n* Among the pregnancies that meet the inclusion criteria, four main cohorts and two sub cohorts of interest will be identified (two Wegovy-exposed cohorts and two comparison cohorts):\n* Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated date of conception to end of pregnancy. Two mutually exclusive cohorts will be identified based on first Wegovy exposure during pregnancy.\n\n  1. Wegovy injection-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.\n  2. Wegovy tablet-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.\n* Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion\u002Fnaltrexone exposure, defined as the following:\n* Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from one day prior to estimated conception date to end of pregnancy.\n* Phentermine or bupropion\u002Fnaltrexone exposure from five days prior to estimated conception date to end of pregnancy.\n* Cohort with Overweight\u002FObesity and at least one weight related comorbid condition-\n* Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg\u002Fm\\^2) on a medical claim during the six month pre-pregnancy period.\n* Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg\u002Fm\\^2 or less than 30 kg\u002Fm\\^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period.\n* No exposure to Wegovy or other AOM during the defined exposure window in pregnancy.\n* Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at less than 14 WGA.\n\nExclusion Criteria:\n\n* Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (that is, 35 days prior to estimated conception date through pregnancy end date).\n* Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date).\n* Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.",[90,91],"CHILD","ADULT",[93,102],{"facility":94,"city":95,"state":96,"zip":97,"country":98,"geoPoint":99},"IBM Watson Health™ Truven Marketscan","Ann Arbor","Michigan","48108","United States",{"lat":100,"lon":101},42.27756,-83.74088,{"facility":103,"city":104,"state":105,"zip":106,"country":98,"geoPoint":107},"Novo Nordisk Investigational Site","Princeton","New Jersey","08540",{"lat":108,"lon":109},40.34872,-74.65905,[],[112],{"name":113,"affiliation":13,"role":114},"(dept. 2834)","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":119},[20,21,19],[],{"nct_id":4,"found":15,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an observational study, meaning researchers will look at existing health records rather than giving participants a treatment. It aims to include 2701 participants.","completed","Observational Study of Wegovy During Pregnancy","This study is looking at the safety of Wegovy during pregnancy. Researchers want to compare the health of mothers and babies exposed to Wegovy during pregnancy with those who were not. They will do this by looking at existing health insurance claims data. The main goal is to see how many babies are born with major birth defects (congenital malformations) up to one year after birth. You might be able to join if you are a woman between 15 and 50 years old, have been pregnant, and your pregnancy ended between June 4, 2021, and February 17, 2034. The study is currently unclear on its recruitment status and plans to include 2701 participants.","The study will track the number of infants with major birth defects from birth up to 1 year of age.",113,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]