Gestational Response, Outcomes, and Weight After GLP-1 Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Gestational weight gain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women
- •Less than or equal to 20 weeks gestation at first visit
- •English speaking
排除标准
- •<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
结局指标
主要结局
Gestational weight gain
时间窗: 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.
次要结局
未报告次要终点
研究者
Johanna Finkle
Clinical Assistant Professor
University of Kansas Medical Center