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Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

PHASE4RECRUITING

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22. 8 mg in Australia) to accelerate fetal lung maturity.

The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11. 4 mg in Australia) of Celestone is non-inferior to the standard double doses.

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Study details:

Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity (total 24 mg in Canada, 22.

8 mg in Australia). There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses (Ninan et al JOGC 2020).

Pregnant people at 22 weeks and 0 days to \< 34 weeks and 6 days' gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection (of normal saline) or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity. Please note: Based on Health Canada's' guidance the study phase is 'Other: Off-Label use'. However, on the clincaltrial.

gov record, 'Phase 4' is selected as this is the most relevant phase and there is no option to select 'Other'. Please note: McMaster University, Canada is the Canadian Regulatory Sponsor and Overall Sponsor, and the University of Adelaide Australia is the Australian Sponsor.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Capable of giving informed, written consent.

Exclusion criteria

Contraindication to corticosteroids

Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc).

Previous participation in this trial (in a previous pregnancy)

Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality)

Demise of one or more fetuses after 14 weeks and 0 days

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2023-07-20

Primary completion: 2026-12-31

Study completion finish: 2029-12-31

Study type

OTHER

Phase

PHASE4

Trial ID

NCT05114096

Intervention or treatment

DRUG: Celestone + placebo

DRUG: Celestone + Celestone

Conditions

• Preterm Birth
• Premature Birth
• Complication of Prematurity
• Obstetric Labor, Premature
• Pregnancy Complications

Condition: Preterm Birth, Premature Birth and more
DRUG: Celestone + placebo and other drugs
Newcastle, New South Wales, Australia and more
Sponsor: McMaster University

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

John Hunter Hospital

Research sites nearby

Select from list below to view details:

John Hunter Hospital
Newcastle, New South Wales, Australia
The University of Newcastle
Newcastle, New South Wales, Australia
The Royal Hospital for Women
Randwick, New South Wales, Australia
The University of New South Wales, St George Hospital
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Single-Dose Celestone 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.	DRUG: Celestone + placebo After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
ACTIVE_COMPARATOR: Double-Dose Celestone 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).	DRUG: Celestone + Celestone After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Perinatal Mortality or Substantial Neonatal Morbidity	Fetal death post-randomization or in hospital neonatal death OR =\> 1 of respiratory morbidity (requiring surfactant \<=48 hrs of life), severe intraventricular hemorrhage (distending/beyond the ventricles, i.e. Grade 3 or 4), or severe bowel problem (necrotizing enterocolitis, Stage 2 or 3)	approximately 1 month

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Death or neurosensory/developmental impairment at 24 months	Death or neurosensory/developmental impairment at 24 months (+/- 6 months; accounting for gestation at birth), mood (anxiety/depression), behavior (aggression), etc as assessed by: 1. Ages and Stages Questionnaire-3 (ASQ) 2. Child Behavior Checklist: 4 subscales 3. Physician diagnosis of cerebral palsy (parent report).	approximately 24 months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)