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Compensation: Varies

Number of Visits: 1

Duration: 1 day

3254 Participants Needed

Antenatal Corticosteroids for Premature Birth
(SNACS Trial)

Recruiting at 45 trial locations

Overseen BySNACS Coordinating Centre

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: McMaster University

Must be taking: Celestone

Must not be taking: Systemic corticosteroids

Disqualifiers: Severe asthma, Lupus, Covid, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a lower dose of the drug Celestone (a corticosteroid) is as effective as the usual higher dose for pregnant individuals at risk of early birth. Celestone aids lung development in babies who might be born prematurely. Researchers aim to determine if a single dose matches the effectiveness of the regular two doses. Pregnant individuals carrying one baby or twins, who have already received one dose of Celestone and are between 22 and nearly 34 weeks pregnant, might be suitable for this trial. As a Phase 4 trial, Celestone is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking systemic corticosteroids for medical conditions during pregnancy, you cannot participate.

What is the safety track record for Celestone?

Research shows that Celestone is generally safe for pregnant individuals at risk of early delivery. It aids in developing a baby's lungs before birth, reducing the likelihood of breathing problems. One study found that 11.6% of babies whose mothers received Celestone experienced breathing issues, compared to 14.4% of those whose mothers received a placebo. This suggests the treatment is effective and usually well-tolerated.

Celestone is approved for use in other situations, providing extensive safety information. Although some studies found no major benefits when used late in pregnancy, the overall safety record remains reassuring. Serious side effects are rare, but discussing potential risks with a healthcare provider is important.¹ ² ³ ⁴ ⁵

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Celestone for premature birth because it's exploring a more targeted approach to dosing. Unlike the standard two-dose regimen for antenatal corticosteroids, this trial is evaluating the potential of a single-dose strategy. This could mean a simpler and more streamlined treatment option for expecting mothers at risk of premature birth. The study aims to determine if a single dose is as effective as the traditional double-dose, potentially reducing exposure to medication while maintaining effectiveness.

What evidence suggests that this trial's treatments could be effective for reducing risks in preterm infants?

Research shows that medications like Celestone, administered before birth, can reduce the risk of death and health problems in premature babies. Studies have found that betamethasone, the main ingredient in Celestone, greatly lowers the chance of breathing problems in newborns when given to women who might deliver early. One study found that administering Celestone to women at risk of slightly early delivery significantly reduces the baby's risk of breathing issues. In this trial, participants will be randomized into two groups: one group will receive the standard double-dose regimen of Celestone, while the other group will receive a single dose followed by a placebo. This trial tests whether one dose works as well as the standard two doses. Existing research strongly supports the treatment's effectiveness, especially for those at risk of early delivery.¹ ² ³ ⁵ ⁶

Who Is on the Research Team?

Kellie Murphy, MD,MSc,FRCSC

Principal Investigator

University of Toronto

Sarah D McDonald, MD,MSc,FRCSC

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals aged 18-55 at risk of preterm birth between 22 and <35 weeks gestation, who can give informed consent and have received only one dose of Celestone within the last 24 hours. It's not for those on systemic corticosteroids, with severe fetal/patient conditions, or previous trial participation.

Inclusion Criteria

I am pregnant, 18-55, at risk of early delivery, and have had one Celestone dose in the last 24 hours.

Capable of giving informed, written consent.

Exclusion Criteria

I am pregnant with a known severe fetal condition.

Previous participation in this trial (in a previous pregnancy)

I am taking corticosteroids for a condition like lupus, severe asthma, or Covid during my pregnancy.

See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a placebo or the standard double dose of Celestone to determine non-inferiority for the primary outcome

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neonatal outcomes and long-term health assessments

up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

Celestone

Trial Overview The SNACS study is testing if a single dose (12 mg in Canada or 11.4 mg in Australia) of Celestone is as effective as the standard double doses for accelerating fetal lung maturity to reduce risks associated with premature births.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Active Control

Group I: Single-Dose CelestoneExperimental Treatment1 Intervention

Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection.

Group II: Double-Dose CelestoneActive Control1 Intervention

Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of Celestone injected intramuscularly (i.e. they will receive the standard double-dose regimen).

Celestone is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Celestone for:

Preterm labor
Respiratory distress syndrome prevention

Approved in United States as Betamethasone for:

Preterm labor
Respiratory distress syndrome prevention

Approved in European Union as Betamethasone for:

Preterm labor
Respiratory distress syndrome prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Sunnybrook Research Institute

Collaborator

Trials

Recruited

216,000+

Women's and Children's Hospital, Australia

Collaborator

Trials

Recruited

32,500+

Medical Research Future Fund

Collaborator

Trials

Recruited

210,000+

University of Adelaide

Collaborator

Trials

Recruited

181,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Medical Research Future Fund

Collaborator

Trials

Recruited

3,300+

Published Research Related to This Trial

In a Phase III study involving 426 patients with mild to moderate psoriasis, the aerosol foam formulation of calcipotriene and betamethasone significantly improved treatment success at week 4 compared to the vehicle, with 53.3% of patients achieving success versus only 4.8% in the control group.

The Cal/BD foam not only provided significant reductions in psoriasis severity (mean mPASI score of 2.0 vs. 5.5) but also offered rapid itch relief, demonstrating both efficacy and a favorable safety profile with minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST).Leonardi, C., Bagel, J., Yamauchi, P., et al.[2022]

Amcinonide cream was classified as a very strong corticosteroid, while prednicarbate cream was found to be moderately strong, based on a series of tests including the vasoconstriction test conducted on healthy young individuals.

The vasoconstriction test proved to be an effective screening method for determining the potency of corticosteroid preparations, with results largely consistent across various other tests, although clinical evaluations are recommended for further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative evaluation of the potencies of external corticoids with various test methods].Koch, EM., Ott, R.[2016]

In a study of 10 patients with sub-total villous atrophy treated with topical corticosteroids for 4 months, 5 patients showed symptomatic improvement along with better red cell folate and urinary xylose levels, indicating some efficacy in managing symptoms of coeliac disease.

Despite some improvements in specific markers and enterocyte height, the overall effectiveness of topical corticosteroids was not superior to prednisolone, and significant suppression of the pituitary adrenal axis was observed in most patients, raising concerns about safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical, biochemical and morphological responses of patients with villous atrophy to oral betamethasone valerate and clobetasone butyrate.Bramble, MG., Watson, AJ., Scott, J., et al.[2018]

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC4349395/

Antenatal Corticosteroids in the Management of Preterm BirthBetamethasone was associated with a significantly reduced risk for neonatal death. Additionally, there were trends of decreased risk for other adverse neonatal ...

2.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC6461224/

Effects of repeat prenatal corticosteroids given to women at ...In this study, we found that repeat prenatal corticosteroids given to women at ongoing risk of preterm birth after an initial course reduced the ...

3.nejm.orgnejm.org/doi/full/10.1056/NEJMoa1516783

Antenatal Betamethasone for Women at Risk for Late ...Administration of betamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications.

4.acog.orgacog.org/clinical/clinical-guidance/committee-opinion/articles/2017/08/antenatal-corticosteroid-therapy-for-fetal-maturation

Antenatal Corticosteroid Therapy for Fetal MaturationRecent data also suggest that betamethasone can be beneficial in pregnant women at high risk of late preterm birth, between 34 0/7 weeks and 36 6/7 weeks of ...

5.bmcpregnancychildbirth.biomedcentral.combmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-021-04246-x

The effects of betamethasone on clinical outcome of the late ...The use of betamethasone in the late preterm period (after 34 weeks of gestation) has no beneficial effects on lung maturity or preventing neonatal adverse ...

6.sciencedirect.comsciencedirect.com/science/article/abs/pii/S0140673622015355

Neonatal outcomes for women at risk of preterm delivery ...Eligible participants were pregnant women aged 18 years or older with a singleton fetus at risk of preterm delivery and already treated with the ...

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