Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a First-Trimester blood test catch pregnancy diabetes sooner?

NCT ID NCT05388643

Diagnosis Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether screening for gestational diabetes in the first trimester (instead of the usual third trimester) can detect the condition earlier in high-risk pregnancies. Researchers will use a combination of risk factors and blood markers to predict GDM. The goal is to see if this early screening is practical and acceptable for pregnant women.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enhanced first-trimester glucose screening with a prediction model using clinical risk factors and blood biomarkers (triglycerides, PAPP-A, lipocalin-2)
What this could lead to
If successful, this could lead to earlier detection and management of gestational diabetes, potentially reducing complications for mothers and babies.
What could go wrong
This is a small early feasibility study (80 participants), so results may not apply broadly. The screening test may not accurately predict GDM, leading to false positives or negatives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\) age greater than or equal to 18 years old, * 2\) singleton gestation less than or equal to 12 weeks at initial obstetric visit, * 3\) receiving prenatal care at UMMHC and plans to deliver at UMMHC, * 4\) able and willing to provide informed consent, * 5\) English or Spanish speaking, and * 6\) are at high risk for developing GDM by ACOG clinical risk factor guidelines. Exclusion Criteria: * 1\) known diagnosis of pre-existing pregestational diabetes, * 2\) plan to receive prenatal care or deliver outside of UMMHC, * 3\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or * 4\) systemic steroid use.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Gestational diabetes mellitus in pregnancy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

gestational diabetes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes mellitus in pregnancy Pregnancy, high risk

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Massachusetts Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01605, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.