Pregnant IndividualsGROWNCT07743567
Gestational Response, Outcomes, and Weight After GLP-1 Use
An observational study of Pregnant Individuals and Obesity & Overweight, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Individuals, Obesity & Overweight, Gestational Weight Gain
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women being seen at The University of Kansas Health System for an initial prenatal visit.
Who may be able to join
- Adult women
- Less than or equal to 20 weeks gestation at first visit
- English speaking
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Molly Fain, 913-588-5478, mfain3@kumc.edu
Johanna Finkle, MD
About this study
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.
Read more
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.
Read the 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.
- Keywords
- Glucagon-like peptide 1 receptor agonist, Pregnancy, Gestational weight gain, Maternal obesity, Pregnancy outcomes, Food noise, Preconception
- Medical subject headings
- Obesity, Overweight, Gestational Weight Gain, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1RA users | Participants with a history of GLP-1RA use. | |
| GLP-1RA nonusers | Participants who have never used a GLP-1RA medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
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.
Measured: From the start of pregnancy to delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start13 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnant IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Finkle, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743567
- Sponsor's protocol ID
- STUDY00162395
- Acronym
- GROW
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be made available to other researchers because data sharing is not included in the study protocol or informed consent.
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.
PubMed 38787563Maya 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.
PubMed 41284263
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Response, Outcomes, and Weight After GLP-1 Use
- ClinicalTrials.gov ID
- NCT07743567
- Acronym / sponsor ID
- GROW / STUDY00162395
- Keywords
- Glucagon-like peptide 1 receptor agonist, Pregnancy, Gestational weight gain, Maternal obesity, Pregnancy outcomes, Food noise, Preconception
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1RA users | – | –Participants with a history of GLP-1RA use. |
| GLP-1RA nonusers | – | –Participants who have never used a GLP-1RA medication. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women being seen at The University of Kansas Health System for an initial prenatal visit.
Key inclusion criteria (3 listed)
- Adult women
- Less than or equal to 20 weeks gestation at first visit
- English speaking
Key exclusion criteria (7 listed)
- <18 years at time of initial visit
- Type 2 diabetes
- History of bariatric surgery
- Multiple gestation
- Cannot consent for themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gestational weight gain
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 38787563Do 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.
- Background: PubMed 41284263Maya 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.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made available to other researchers because data sharing is not included in the study protocol or informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Individuals and Obesity & Overweight, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Fain (913-588-5478, mfain3@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weight gain (time frame: From the start of pregnancy to delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07743567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.