Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth

NCT04494529 | Completed Phase 3

• 1 other identifier: SNACS Pilot Trial
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants. Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone. The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).

Conditions

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

Keywords

Premature birth; Preterm birth; Obstetric labor; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormone Substitutes; Hormone Antagonists; Physiological Effect of Drugs; Anti-Asthmatic Agents; Respiratory System Agents

Outcome Measures

Primary Outcomes (2)

• Feasibility of conducting a full-scale trial

  Feasibility of conducting a full-scale trial will be defined as =\> 50% recruitment of approached participants

  5-6 months

• Feasibility of the study protocol

  Feasibility of the study intervention will be defined as =\> 98% compliance with the protocol

  5-6 months

Secondary Outcomes (18)

• Process outcomes

  5-6 months

• Neonatal mortality rates

  5-6 months

• Respiratory morbidity rates

  5-6 months

• Severe intraventricular haemorrhage rates

  5-6 months

• Rates of severe bowel problems due to necrotizing enterocolitis

  5-6 months

Study Arms (2)

Single-Dose (12 mg betamethasone + placebo)

PLACEBO COMPARATOR

The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed. Participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection instead of the standard 2nd dose of 12 mg of betamethasone (i.e. they will receive the experimental single-dose regimen, total 12 mg of betamethasone only from the first injection).

Drug: 12 mg betamethasone + placebo

Double-Dose (12 mg betamethasone + 12 mg betamethasone)

ACTIVE COMPARATOR

The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed. Participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of 12 mg of betamethasone injected intramuscularly (i.e. they will receive the standard double-dose regimen, total 24 mg of betamethasone).

Drug: 24 mg betamethasone

Interventions

12 mg betamethasone + placebo DRUG

After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.

Single-Dose (12 mg betamethasone + placebo)

24 mg betamethasone DRUG

After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Active Comparator" group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone.

Double-Dose (12 mg betamethasone + 12 mg betamethasone)

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women at risk of preterm birth with a singleton or twins between =\>22+0/7 and \<=34+6/7 weeks' gestation
• Pregnant with either singletons or twins
• Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours
• All fetuses are alive and without compromise as per ultrasound or fetal heart monitor
• Is capable of giving informed, written consent in English

You may not qualify if:

• Any contraindications to receiving corticosteroids
• Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)
• Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone
• Had any previous participation in this trial
• Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18, Trisomy 21, etc.)
• Pregnant with monoamniotic/monochorionic (Mono/Mono) twins

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8N3Z5, Canada

Location

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sarah D McDonald, MD, MSc, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

• Kellie Murphy, MD, MSc, FRCSC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot double-blind randomized controlled trial

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 31, 2020
• Study Start: March 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)