The Wegovy
Pregnancy Registry

What is a Registry and why is it important?

A Pregnancy Registry is a study that collects health information from pregnant women, including those who take prescription medicines during pregnancy. Information is also collected on the newborn infant.

Pregnancy illustration

Who is eligible to participate?

Patients may be eligible if:

  • They are currently pregnant or have been pregnant in the past year
  • They are willing to share more information via a 20-minute phone call with the research team sometime within 1-2 weeks of enrollment

AND

  • Their BMI prior to becoming pregnant was:
    • 27 to 30 kg/m2 (overweight) with weight-related comorbidities
    • 30 kg/m2 or more (obesity)

OR

  • They have used Wegovy® (semaglutide) for weight-loss during pregnancy or in the 5 weeks prior to pregnancy

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

Complete the Potential Participant Contact Request Form here and a Registry staff member will contact you.

Call the registry team toll-free at
1-877-390-2760 (hours of operation 8.30am – 5.00 pm EST Monday-Friday)

What is Wegovy® (semaglutide)?

Wegovy® (semaglutide) is a prescription medicine made by Novo Nordisk A/S that is used as an adjunct to a reduced caloric diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

  • 30 kg/m2 or greater (obesity), or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.

Women of childbearing age (15-44 years) are particularly vulnerable to weight gain, and weight gain during this time is strongly associated with adverse health outcomes later in life (Dutton 2016; Gordon-Larsen 2010; Norman 2003; Zheng 2017). Pre-pregnancy obesity rates among women aged 15 to 44 are reported to be around 25% in the United States (Wang 2021). Obesity during the childbearing years has been associated with adverse pregnancy outcomes for the mother (e.g., gestational diabetes, pre-eclampsia, gestational hypertension, antenatal anxiety, and postpartum depression), as well as for the babies (e.g., pre-term birth, and babies who are large for gestational age) (Athukorala 2010; Oteng-Ntim 2013).

Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of the use of weight loss medications during pregnancy on pregnancy and infant outcomes.

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the website portal or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctors’ visits or additional testing
  • No changes to patients’ medications or care

Eligible patients and their healthcare providers will receive compensation for providing data to the registry.

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will also be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal pre-pregnancy weight and height at various time points
  • Maternal obstetrical history
  • Family history of congenital malformations
  • Maternal history of obesity or overweight, including date of diagnosis and weight-related comorbid conditions
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • Infant growth and development information

Healthcare providers will be compensated when they submit data to the registry.

Eligible patients will be asked to provide information to the registry at enrollment, including basic demographic information (e.g., race, ethnicity, education), height and weight.

Thank you for your support in recruiting potential participants.

References

Athukorala C, Rumbold AR, Willson KJ, Crowther CA. The risk of adverse pregnancy outcomes in women who are overweight or obese. BMC Pregnancy Childbirth. 2010;10:56.

Dutton GR, Kim Y, Jacobs DR, Li X, Loria CM, Reis JP, et al. 25-year weight gain in a racially balanced sample of U.S. adults: The CARDIA study. Obesity (Silver Spring). 2016;24(9):1962-1968.

Gordon-Larsen P, The NS, Adair LS. Longitudinal trends in obesity in the United States from adolescence to the third decade of life. Obesity (Silver Spring). 2010;18(9):1801-1804.

Norman JE, Bild D, Lewis CE, Liu K, West DS, Study C. The impact of weight change on cardiovascular disease risk factors in young black and white adults: the CARDIA study. Int J Obes Relat Metab Disord. 2003;27(3):369-376.

Oteng-Ntim E, Kopeika J, Seed P, Wandiembe S, Doyle P. Impact of obesity on pregnancy outcome in different ethnic groups: calculating population attributable fractions. PLoS One. 2013;8(1):e53749.

Wang MC, Freaney PM, Perak AM, Greenland P, Lloyd-Jones DM, Grobman WA, et al. Trends in Prepregnancy Obesity and Association With Adverse Pregnancy Outcomes in the United States, 2013 to 2018. J Am Heart Assoc. 2021;10(17):e020717.

Zheng Y, Manson JE, Yuan C, Liang MH, Grodstein F, Stampfer MJ, et al. Associations of Weight Gain From Early to Middle Adulthood With Major Health Outcomes Later in Life. JAMA. 2017;318(3):255-269.

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