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Twin pregnancy breakthrough? lifestyle coaching aims to prevent early birth

NCT ID NCT07270640

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests a lifestyle intervention for women pregnant with twins. The program includes 8 coaching sessions on nutrition, exercise, and stress reduction. The goal is to see if it can delay delivery by at least one week, improving outcomes for mothers and babies. This pilot phase checks if the approach is feasible before a larger trial.

What this could mean

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

Active substance
lifestyle intervention (nutrition, physical activity, stress reduction coaching)
What this could lead to
If successful, this could lead to a simple, non-drug way to help women carry twins longer, reducing health risks for babies.
What could go wrong
This is a small pilot study testing feasibility, not effectiveness. The full trial is needed to see if it really works, and results may not apply to all twin pregnancies.

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 81 people

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

Started

Dec 2025

Expected to finish

Jun 2027

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: * Prior to any randomization or intervention, participants must have provided voluntary written informed consent. * Diagnosis of dichorionic twin pregnancies must align with the acceptance criteria. * Participants must be recruited before the 14th week of gestation. * Proficiency in Dutch, English, or French is required.- Exclusion Criteria: * Participant has a history of pre-existing diseases or condition impacting their diet: 1. pre-gestational diabetes 2. severe heart disease, 3. chronic renal disease, 4. celiac disease, 5. inflammatory bowel disease, 6. post-bariatric surgery * Participant has a history of pre-existing diseases or conditions impacting their physical activity ability: 1. Chronic Obstructive Pulmonary Disease (COPD) 2. Severe Asthma. 3. Fibromyalgia 4. Osteoarthritis 5. Chronic Pain Syndromes 6. Spinal Cord Injuries. 7. Multiple Sclerosis (MS) 8. Parkinson's Disease 9. History of a Stroke 10. Drug resistance Epilepsy * Participants identified with mental vulnerabilities requiring specific care pathways by Born in Belgium (BIB) or local screening tool. * Participants with a History of Mental Health Disorders 1. Post-Traumatic Stress Disorder (PTSD) 2. Anxiety Disorders 3. Depressive Disorders 4. Bipolar Disorder 5. Obsessive-Compulsive Disorder (OCD) 6. Schizophrenia or schizoaffective disorder * Inability to give informed consent * No knowledge of Dutch, English or French * First trimester diagnosis of severe congenital anomaly in one or both twins * First trimester foetal demise of one or both twins * Rupture of membranes prior to recruitment * Participation in any other interventional Study

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As listed by the trial registrant

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

Twin pregnancy, dichorionic

How to take part

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

  1. The places running it

    4 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

  • CHU Brugmann

    RECRUITING

    Brussels, 1020, Belgium

  • Hôpital de la Citadelle

    RECRUITING

    Liège, 4000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, 3600, Belgium