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Tight vs. moderate blood sugar control in pregnancy: which is better?

NCT ID NCT03610178

Knowledge-focused Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 850 pregnant women with gestational diabetes to see if very tight blood sugar targets or moderate targets lead to better outcomes for mothers and babies. It also explored how different targets affect genes in the baby. Women were assigned to lifestyle changes and insulin if needed. The goal is to find the safest approach to manage blood sugar during pregnancy.

What this could mean

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

Active substance
lifestyle modification (diet and exercise) and insulin therapy if needed
What this could lead to
If successful, this could help determine the best blood sugar targets for managing gestational diabetes and improve outcomes for mothers and babies.
What could go wrong
This is a completed study, but results may not apply to all populations. The genetic findings are exploratory and may not lead to direct clinical changes.

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

850 people

The number who actually took part.

Started

Aug 2015

Finished

Dec 2024

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Pregnant women with GDM diagnosed according to the Russian national consensus and the recommendations of the International Association of Diabetes and Pregnancy Study Groups (fasting glucose of ≥5.1 mmol/L, and/or ≥10.0 mmol/L after 1 h, and/or ≥8.5 mmol/L after 2 h in oral glucose tolerance test (OGTT) with 75 g of glucose). * Gestational age at the time of inclusion in the study 12 weeks 0 days - 31 weeks 6 days * For control group: pregnant women with normal glucose tolerance confirmed by OGTT at 24-31 weeks of gestation. Exclusion Criteria: * Diabetes mellitus type 1 and tipe 2 * Other deseases that affect methabolism of carbohydrates * Use of drugs that affect methabolism of carbohydrates * Malformations of the fetus identifired prior to inclusion to the study.

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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

Contacts and locations

Locations

  • Almazov NMRC

    Saint Petersburg, 197341, Russia

More trials for these conditions

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