NCT07743567

Brief 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.
  • 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Apr 2026Apr 2028

Study Start

First participant enrolled

April 13, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

Glucagon-like peptide 1 receptor agonistPregnancyGestational weight gainMaternal obesityPregnancy outcomesFood noisePreconception

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the start of pregnancy to delivery.

Study Arms (2)

GLP-1RA users

Participants with a history of GLP-1RA use.

GLP-1RA nonusers

Participants who have never used a GLP-1RA medication.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women being seen at The University of Kansas Health System for an initial prenatal visit.

You may qualify if:

  • Adult women
  • Less than or equal to 20 weeks gestation at first visit
  • English speaking

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (2)

  • 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: 38787563BACKGROUND
  • 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: 41284263BACKGROUND

MeSH Terms

Conditions

ObesityOverweightGestational Weight GainPregnancy in Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight GainBody Weight ChangesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations