The Novo Nordisk Pregnancy Registry study is sponsored and funded by Novo Nordisk, with Imperial College Healthcare NHS Trust as the participating organisation conducting the study.
What is a Registry and why is it important?
A pregnancy registry is a study that collects health information from women who take prescription medicines when they are pregnant. Information is also collected on the newborn baby. This information is compared with women who have not taken medicine or have taken other medicines during pregnancy.
Patients may be eligible if they are a pregnant woman who is:
And have been diagnosed with either:
Women may be eligible to participate whether or not they’ve taken weight loss medications during pregnancy.
Would you like to enrol a patient?If you have patients who you think may be eligible, you can help them enrol by having them:
Complete the Contact Request Form and a Registry team member will contact them
Call the study phone number* at
07551 298403
(Monday-Friday, 8:30-5:00)
*normal costs apply
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 (Norman 2003; Zheng 2017). 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 and infant outcomes.
Eligible patients and their healthcare professionals 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:
The pregnant woman’s healthcare professional will be asked to provide data at enrolment, approximately the end of the second trimester, and at pregnancy outcome. For live-born infants, healthcare professionals will also be asked to provide data at approximately 4 and 12 months after delivery.
The following data will be collected:
Eligible patients will be asked to provide information to the registry at enrolment, including basic demographic information (e.g., race, ethnicity, education), height and weight.
References
Vestergaard C, Wollenberg A, Barbarot S, et al. European task force on atopic dermatitis position paper: Treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol 2019;33:1644-59.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.
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.
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.