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Could half the usual steroid dose protect preterm babies just as well?

NCT ID NCT05114096

Disease control Sponsor: McMaster University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving pregnant people at risk of preterm birth half the usual dose of a steroid (Celestone) works as well as the full dose to prevent serious health problems in their babies. About 3,250 participants will receive either one or two doses after an initial shot. The goal is to see if a lower dose can still reduce risks like breathing trouble and brain bleeding without losing effectiveness.

What this could mean

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

Active substance
Celestone (betamethasone)
What this could lead to
If successful, this could show that a lower steroid dose is just as effective for preterm babies, reducing potential side effects from higher doses.
What could go wrong
This is a large phase 4 trial, but the lower dose might not protect babies as well as the standard dose, increasing risks of breathing problems or other complications.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,254 people

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

Started

Jul 2023

Expected to finish

Dec 2029

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 to 55 years

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. Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and \<34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours 2. Capable of giving informed, written consent. Exclusion Criteria: 1. Contraindication to corticosteroids 2. Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc). 3. Previous participation in this trial (in a previous pregnancy) 4. Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality) 5. Demise of one or more fetuses after 14 weeks and 0 days

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Conditions

The condition(s) this trial relates to.

Obstetric Labor, Premature pregnancy disorder Premature Birth newborn respiratory distress syndrome prevention target

As listed by the trial registrant

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

Complication of prematurity Obstetric labor, premature Pregnancy complications Premature birth Preterm birth

How to take part

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

  1. The places running it

    25 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

  • (CIUSSS de l'Estrie-CHUS); Université de Sherbrooke

    RECRUITING

    Sherbrooke, Quebec, Canada

  • Alberta Health Services; University of Alberta

    RECRUITING

    Edmonton, Alberta, Canada

  • Dalhousie University; Izaak Walton Killam Health

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Dr. Everett Chalmers Regional Hospital

    RECRUITING

    Fredericton, New Brunswick, Canada

  • Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre

    NOT_YET_RECRUITING

    Surrey, British Columbia, Canada

  • Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • McGill University, McGill University Health Center, Royal Victoria Hospital

    RECRUITING

    Montreal, Quebec, Canada

  • McMaster University

    RECRUITING

    Hamilton, Ontario, Canada

  • Memorial University, Eastern Health

    NOT_YET_RECRUITING

    St. John's, Newfoundland and Labrador, Canada

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Queen's University, Kingston General Hospital Health Sciences Centre

    RECRUITING

    Kingston, Ontario, Canada

  • Royal Columbian Hospital

    NOT_YET_RECRUITING

    New Westminster, British Columbia, Canada

  • Sir Mortimer B. Davis Jewish General Hospital; McGill University

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • Sunnybrook Health Sciences Center

    RECRUITING

    Toronto, Ontario, Canada

  • The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal

    RECRUITING

    Montreal, Quebec, Canada

  • The Moncton Hospital, Horizon Health Network

    RECRUITING

    Moncton, New Brunswick, Canada

  • University of British Columbia; BC Women's Hospital

    NOT_YET_RECRUITING

    Vancouver, British Columbia, Canada

  • University of Calgary, Cumming School of Medicine

    RECRUITING

    Calgary, Alberta, Canada

  • University of Manitoba, Health Sciences Centre

    NOT_YET_RECRUITING

    Winnipeg, Manitoba, Canada

  • University of Manitoba; St. Boniface General Hospital

    NOT_YET_RECRUITING

    Winnipeg, Manitoba, Canada

  • University of Ottawa; The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, Canada

  • University of Saskatchewan, Regina General Hospital

    NOT_YET_RECRUITING

    Saskatoon, Saskatchewan, Canada

  • Université Laval, Centre de recherche du CHU de Québec

    RECRUITING

    Québec, Quebec, Canada

  • Victoria General Hospital

    NOT_YET_RECRUITING

    Victoria, British Columbia, Canada

  • Western University; London Health Sciences Centre, Victoria Hospital

    RECRUITING

    London, Ontario, Canada

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