I8F-MC-B016 Tirzepatide Pregnancy Registry - A Multi-Country Registry-Based Observational Study to Assess Maternal, Fetal, and Infant Outcomes Following Treatment with Tirzepatide for Weight Management During Pregnancy

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TIRZEPATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BX16) tirzepatide

  tirzepatide

Population studied

• Special population of interest:
  Pregnant women

Study design details

• Study design:
  The Tirzepatide Pregnancy Registry study is a multi-country, prospective, observational cohort study designed to evaluate the association between tirzepatide exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
• Main study objective:
  The aim of the Tirzepatide Pregnancy Registry study is to compare the maternal, fetal, and infant outcomes of individuals treated with tirzepatide for weight management during pregnancy (tirzepatide exposed cohort) with outcomes in two comparator cohorts:;  Anti-obesity medication [AOM] active comparator cohort: Individuals who are treated with pharmacotherapy other than tirzepatide or other therapies with GLP-1 receptor agonist (GLP-1 RA) activity for weight management during pregnancy ;  AOM unexposed comparator cohort: Individuals who have obesity or are overweight with at least one weight; related comorbid condition at the time of conception; and who are not treated with tirzepatide, GLP-1 RA ; therapies, or any products for weight management during pregnancy; ; The primary objective is to describe and compare the overall prevalence of major congenital malformations (MCM) among individuals treated with tirzepatide for weight management during pregnancy relative to the two comparator cohorts of pregnant individuals (AOM active comparator cohort and AOM unexposed comparator cohort).; ; The secondary objective is to describe and compare the prevalence of maternal pregnancy complications, fetal and infant outcomes other than MCM, and postnatal growth and development outcomes between pregnant individuals treated with tirzepatide for weight management during pregnancy and the two; comparator cohorts of pregnant individuals (AOM active comparator cohort and AOM unexposed comparator cohort). The secondary outcomes of interest are as follows:; Maternal pregnancy complications;  Gestational diabetes;  Pregnancy-induced hypertension;  Pre-eclampsia;  Eclampsia; Fetal outcomes;  Spontaneous abortion (SAB) ;  Induced abortion;  Stillbirth ; Infant outcomes;  Minor congenital malformations;  Preterm birth ;  Small for gestational age (SGA); Postnatal growth and development outcomes;  Postnatal growth deficiency (up to one year of age);  Infant developmental delay (up to one year of age);