Gestational Response, Outcomes, and Weight After GLP-1 Use (GROW)
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Molly Fain
- 电话号码:913-588-5478
- 邮箱:mfain3@kumc.edu
学习地点
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Kansas
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Kansas City、Kansas、美国、66160
- 招聘中
- University of Kansas Medical Center
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接触:
- Molly Fain
- 电话号码:913-588-5478
- 邮箱:mfain3@kumc.edu
-
首席研究员:
- Johanna Finkle, MD
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
GLP-1RA users
Participants with a history of GLP-1RA use.
|
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GLP-1RA nonusers
Participants who have never used a GLP-1RA medication.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gestational weight gain
大体时间:From the start of pregnancy to delivery.
|
Total gestational weight gain, calculated from clinical weight measurements recorded in the electronic medical record and compared between participants with preconception GLP-1RA exposure and those without exposure.
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From the start of pregnancy to delivery.
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00162395
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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