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Набор по приглашению NCT05503927

A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy

— Наблюдательное Pregnancy Obesity Overweight

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No Intervention.
Кому может быть актуально
Состояния в реестре: Pregnancy, Obesity, Overweight. Базовые параметры: 15 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Wegovy® (Semaglutide) Database Study: A Population-based Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy During Pregnancy

Обзор

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.

Вмешательства

  • Другое No Intervention
    This is a non-interventional study, therefore no intervention is used.

Первичные конечные точки

  • Number of Infants with Major Congenital Malformation (MCM) [Срок оценки: Birth up to 1 year of age]
Вторичные конечные точки (7)
  • Number of Infants Experiencing Small for Gestational Age (SGA) Birth [Срок оценки: Birth up to 1 year of age]
  • Number of infants with Developmental Delay [Срок оценки: Birth up to 1 year of age]
  • Number of Infants With Postnatal Growth Deficiency [Срок оценки: Birth up to 1 year of age]
  • Number of Pregnant Participants Experiencing Stillbirth [Срок оценки: up to 37 weeks of gestational age]
  • Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB) [Срок оценки: up to 37 weeks of gestational age]
  • Number of Pregnant Participants With Preterm Delivery [Срок оценки: Up to 37 weeks of gestational age]
  • Number of Pregnant Participants With Pre-eclampsia/eclampsia [Срок оценки: Up to 37 weeks of gestational age]

Критерии участия

Критерии включения

  • 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.
  • 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):
  • 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.
  • Wegovy injection-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.
  • Wegovy tablet-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy.
  • Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone 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/naltrexone exposure from five days prior to estimated conception date to end of pregnancy.
  • Cohort with Overweight/Obesity 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/m\^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/m\^2 or less than 30 kg/m\^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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • IBM Watson Health™ Truven Marketscan — Ann Arbor
  • Novo Nordisk Investigational Site — Princeton

Идентификаторы

NCT: NCT05503927 · NN9536-4971 · U1111-1273-4411

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗