Maternal Abdominal Morphology Assessment

NCT ID: NCT06784674

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-06

Study Completion Date

2031-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy. The MAMA study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes.

The MAMA study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. Women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the MAMA study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As pancreas size is thought to reflect pancreatic insulin production and/or islet mass, monitoring pancreas size during and after pregnancy may advance the investigators' understanding of gestational diabetes mellitus (GDM) incidence and progression. Information on pancreas size changes during pregnancy, typical fetal pancreatic development, the relationship between pancreas size and GDM risk, and the relationship between pancreas size and neonatal hypoglycemia are largely unknown. Through this project, magnetic resonance imaging (MRI) will be used to measure changes in pancreas size during pregnancy and the effect of maternal diabetes on these measures.

This prospective cohort study is observational and will include up to 87 pregnant women who are between 18-54 years old. Study visits will take place at approximately 15-18 weeks gestation, 24-28 weeks gestation, 34-38 weeks gestation, and 1 year-1 year and 2 months postpartum. At each study visit, participants will self-report their height and weight, have their blood pressure measured, have their blood drawn, have an HbA1c finger stick test, participate in oral glucose tolerance testing (OGTT), complete an MRI scan, and undergo continuous glucose monitoring (CGM).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related Infant Development Pancreas Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MAMA Study Participants

Approximately 87 pregnant women, aged 18-54, living in the Greater Austin area, will participate in the MAMA study. The MAMA study is an observational study.

No intervention

Intervention Type OTHER

Observational study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

Observational study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women, with a singleton gestation
* Age 18 - 54 years at screening
* Gestational age \< 14 weeks
* Willing to commit to 1 year postpartum follow up
* Planning to remain in geographical vicinity of Austin for 1 year after delivery

Exclusion Criteria

* Presence of any mechanically or magnetically activated implants
* Claustrophobia
* Other contraindication for MRI
* BMI ≥ 38.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)
Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John Virostko

John Virostko, Associate Professor, Department of Diagnostic Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jack Virostko, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dell Medical School Health Discovery Building

Austin, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jack Virostko, Ph.D.

Role: CONTACT

512-495-5126

Ingrid Harris, MPH

Role: CONTACT

512-471-0999

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ingrid Harris, MPH

Role: primary

5124710999

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00005491

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prediction of Fetal Lung Maturity
NCT03159234 COMPLETED NA
Healthy Lifestyle in Pregnancy
NCT01585454 WITHDRAWN