A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
This study is checking the safety of a medicine called Wegovy if it's taken during pregnancy. It's for women who are pregnant and have used Wegovy for obesity or if they are overweight with related health problems. Researchers will carefully watch the health of both the mother and baby, comparing them to mothers with similar health conditions who didn't take Wegovy during pregnancy. They'll specifically look at how the baby develops during its first year of life. This helps us understand any potential effects of Wegovy on pregnancy outcomes and infant health.
At a glance
What is this study about?
This research is an important study aiming to understand more about the use of a medicine called Wegovy during pregnancy. Wegovy is used to help people with obesity or who are overweight, especially when they have other related health conditions. The study is called an 'observational registry,' which means doctors will gather information about women who have already been exposed to Wegovy during pregnancy, rather than asking anyone to start taking it.
The main goal is to see if taking Wegovy during pregnancy has any effect on the mother's health, how the baby develops, and the baby's health in its first year of life. To do this, they will compare the health outcomes of these mothers and babies with a group of mothers who also have obesity or are overweight with similar health conditions but did not use Wegovy or similar medicines during their pregnancy.
By carefully collecting this information, researchers hope to get a clearer picture of whether Wegovy might affect pregnancy or babies, providing valuable knowledge for patients and doctors in the future. It's about learning more from real-life situations.
Key takeaways
- This study collects information about health outcomes for mothers and babies.
- It focuses on women who took Wegovy for weight management during pregnancy.
- It compares their health with similar mothers who did not take Wegovy.
- The baby's health will be checked at 4 and 12 months after birth.
- This research helps understand Wegovy's safety during pregnancy.
- You won't receive new treatments or change your medical care by joining.
Who may be eligible?
To be part of this study, you need to be a woman between 15 and 50 years old and either currently pregnant or have recently been pregnant. You must live in one of the countries where the study is taking place.
For those who were exposed to Wegovy, you must have taken at least one dose of Wegovy during your pregnancy for obesity or being overweight, alongside at least one other weight-related health issue.
For those who were not exposed, you must have had obesity or been overweight with at least one weight-related health issue when you became pregnant, and you must not have taken Wegovy or similar medicines during your pregnancy. It's important that you are willing to let your healthcare providers share information with the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman between 15 and 50 years old?
- Are you currently pregnant or have you recently been pregnant?
- If you took Wegovy, did you take at least one dose during pregnancy for obesity/overweight with another health condition?
- If you didn't take Wegovy, did you have obesity/overweight with another health condition when you got pregnant and didn't take Wegovy or similar medicines during pregnancy?
- Are you willing to let your doctors share your health information for the study?
What does participation involve?
This study is observational, which means you won't be asked to change any medications you are taking or make any specific doctor's visits because of the study. Your doctors will simply share information about your pregnancy and your baby's health with the researchers.
If you take part, your medical information will be collected from your healthcare providers. For the mothers who took Wegovy, details about your pregnancy, the birth, and your baby's health will be noted. For all babies in the study, their health and development will be checked at 4 months and again at 12 months after they are born. This follow-up will last for the baby's first year of life.
Potential risks and benefits
Locations (3)
- Novo Nordisk Investigational SiteVerified postcodePrinceton, United States
- Novo Nordisk Investigational SiteVerified postcodeMadrid, Spain
- Novo Nordisk Investigational SiteVerified postcodeLondon, United Kingdom
Common questions
What is Wegovy?
Wegovy is a medicine used to help people lose weight, especially if they have obesity or are overweight with other health conditions.
Will I be given Wegovy if I join this study?
No, this study is about observing what happened to women who have already used Wegovy, not giving anyone new medicine.
What kind of information will be collected?
Information about your pregnancy, your baby's health at birth, and their development in the first year will be collected from your medical records.
Will my information be kept private?
Yes, all your personal information will be kept confidential and handled according to strict privacy rules.
How long will the study follow my baby?
The study will collect information about your baby's health for their first year of life.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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