- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07743567
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Molly Fain
- Telefonnummer: 913-588-5478
- E-post: mfain3@kumc.edu
Studieorter
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160
- Rekrytering
- University of Kansas Medical Center
-
Kontakt:
- Molly Fain
- Telefonnummer: 913-588-5478
- E-post: mfain3@kumc.edu
-
Huvudutredare:
- Johanna Finkle, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
GLP-1RA users
Participants with a history of GLP-1RA use.
|
|
GLP-1RA nonusers
Participants who have never used a GLP-1RA medication.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gestational weight gain
Tidsram: 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.
|
From the start of pregnancy to delivery.
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Näringsstörningar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Övernäring
- Kroppsvikt
- Graviditetskomplikationer
- Förändringar i kroppsvikt
- Viktökning
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Tecken och symtom
- Gestational viktökning
- Övervikt
- Fetma
- Graviditet i fetma
Andra studie-ID-nummer
- STUDY00162395
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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