Gestational Response, Outcomes, and Weight After GLP-1 Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnant Individuals, Obesity & Overweight, Gestational Weight Gain. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to learn if using GLP-1RA medications for weight loss before pregnancy influences gestational weight gain and pregnancy outcomes. The main aims of the study are to: * Compare gestational weight gain between women with preconception GLP-1RA exposure and those without exposure. * Compare obstetrical outcomes between women with preconception GLP-1RA exposure and those without exposure. Researchers will compare pregnant women with a history of GLP-1RA use to pregnant women who have not used a GLP-1RA to compare differences. Participants will be asked to complete questionnaires at multiple timepoints during and after pregnancy that ask questions about medication history, thoughts and feelings around food, etc.
Detailed description
Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have become widely used for the treatment of obesity because they produce substantial weight loss and improve cardiometabolic health. As use of these medications increases among women of reproductive age, more individuals are conceiving after treatment with GLP-1RAs. Because GLP-1RAs are not recommended during pregnancy, therapy is typically discontinued before conception or immediately after pregnancy is recognized. Although weight regain following GLP-1RA discontinuation has been demonstrated in nonpregnant populations, the effects of discontinuation on gestational weight gain and pregnancy outcomes remain poorly understood.
The GROW study is a prospective observational cohort study designed to evaluate the association between preconception GLP-1RA exposure and maternal and neonatal outcomes. Approximately 400 pregnant women aged 18 to 45 years who are at or before 20 weeks of gestation will be enrolled. Participants will be classified according to whether they used a GLP-1RA within the three years prior to conception. This is an observational study, and no investigational treatment or intervention will be provided.
Participants will complete questionnaires at baseline, during late pregnancy (32-36 weeks gestation), 6-10 weeks postpartum, and 6 months postpartum. Information collected will include demographic characteristics, history of GLP-1RA use, food noise, dietary intake (optional), addictive-like eating behaviors, and infant feeding practices. Maternal and neonatal clinical outcomes will be abstracted from the electronic medical record.
The primary objective is to compare gestational weight gain between women with and without preconception GLP-1RA exposure. Secondary objectives are to compare obstetrical outcomes, food noise, and dietary intake between groups. Findings from this study will improve understanding of the effects of GLP-1RA discontinuation before pregnancy and may help inform counseling and clinical management of women who conceive after treatment with these medications.
Primary outcome measures
- Gestational weight gain [Time frame: From the start of pregnancy to delivery.]
Eligibility criteria
Inclusion criteria
- Adult women
- Less than or equal to 20 weeks gestation at first visit
- English speaking
Exclusion criteria
- <18 years at time of initial visit
- Type 2 diabetes
- History of bariatric surgery
- Multiple gestation
- Cannot consent for themselves
- Cannot read and speak English
- Incarcerated
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Publications
- Do D, Lee T, Peasah SK, Good CB, Inneh A, Patel U. GLP-1 Receptor Agonist Discontinuation Among Patients With Obesity and/or Type 2 Diabetes. JAMA Netw Open. 2024 May 1;7(5):e2413172. doi: 10.1001/jamanetworkopen.2024.13172. PMID 38787563
- Maya J, Pant D, Fu Y, James K, Batlle C, Hsu S, Soria-Contreras DC, Shook LL, Mow C, Hivert MF, Thaweethai T, Powe CE. Gestational Weight Gain and Pregnancy Outcomes After GLP-1 Receptor Agonist Discontinuation. JAMA. 2025 Dec 23;334(24):2186-2196. doi: 10.1001/jama.2025.20951. PMID 41284263
Identifiers
NCT: NCT07743567 · STUDY00162395