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Pregnancy after Weight-Loss surgery: blood sugar swings may harm baby

NCT ID NCT05084339

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how blood sugar patterns change during pregnancy in women who have had gastric bypass or sleeve gastrectomy. Researchers want to see if these changes lead to smaller babies or other complications. They are also testing if a continuous glucose monitor (CGM) can better detect gestational diabetes in these women. The study will follow 190 pregnant women, half with prior bariatric surgery, using a blinded CGM at four points 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
continuous glucose monitor (CGM)
What this could lead to
If successful, this could help doctors better manage blood sugar in pregnant women after bariatric surgery, potentially reducing risks like small babies.
What could go wrong
This is an observational study, not a treatment trial. It may only confirm known risks without offering new solutions, and results may not apply to all surgery types.

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.

Participants

About 190 people

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

Started

Jan 2023

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.

Who is studied

95 pregnant women with a history of bariatric surgery (RYBG or SG) and 95 age-and BMO matched pregnant women without history of bariatric surgery

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days * for the group with bariatric surgery: history of gastric bypass (RYBG) or sleeve gastrectomy (SG) * Participants need to speak and understand Flemish, French or English and have e-mail access. Exclusion Criteria: * multiple pregnancy * pregnancy ≥12 weeks * other types of bariatric surgery than RYBG or SG * known pregestational diabetes * a physical or psychological disease likely to interfere with the conduct of the study * medications known to interfere with glucose metabolism.

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As listed by the trial registrant

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

Bariatric surgery status complicating pregnancy

How to take part

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

  1. The places running it

    8 sites. 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

  • AZ Groeninge Kortrijk

    RECRUITING

    Kortrijk, Belgium

  • AZ St-Jan Brugge

    RECRUITING

    Bruges, Belgium

  • Imelda Bonheiden

    RECRUITING

    Bonheiden, Belgium

  • OLV-Aalst-Asse

    RECRUITING

    Aalst, Belgium

  • UZ Gent

    RECRUITING

    Ghent, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • UZA

    RECRUITING

    Antwerp, Belgium

  • ZNA Antwerpen

    RECRUITING

    Antwerp, Belgium