Single dose of corticosteroids for pregnant individuals at risk of preterm delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether a single lower dose of Celestone, an antenatal corticosteroid, is as effective as the standard double dose in reducing neonatal death and morbidity in preterm infants. Pregnant individuals between 22 weeks and less than 34 weeks of gestation who are at risk of preterm birth will be randomized to receive either the standard double dose or a placebo after having received an initial dose of Celestone. The primary outcome will assess the rates of perinatal mortality and substantial morbidity. This study aims to provide evidence on the efficacy of a single dose compared to the standard treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Calgary, Cumming School of Medicine
  Calgary, Alberta, Canada Recruiting
• Alberta Health Services; University of Alberta
  Edmonton, Alberta, Canada Recruiting
• Dr. Everett Chalmers Regional Hospital
  Fredericton, New Brunswick, Canada Recruiting
• The Moncton Hospital, Horizon Health Network
  Moncton, New Brunswick, Canada Recruiting
• Dalhousie University; Izaak Walton Killam Health
  Halifax, Nova Scotia, Canada Recruiting
• McMaster University
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Sarah D McDonald, MD,MSc,FRCSC — McMaster University
• Study coordinator: Sarah D McDonald, MD,MSc,FRCSC
• Email: mcdonals@mcmaster.ca
• Phone: 905-525-9140

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A decision support tool for families facing preterm delivery decisions

  This study is testing a new tool to help families make better decisions about care for their premature babies born between 22 and 26 weeks of pregnancy.

  Recruiting at 12 sites Indiana University · San Diego, California and 11 other locations · NCT05264779

• How higher temperatures affect pregnant women and newborns in rural Sindh

  This cohort will test whether exposure to high environmental temperatures during pregnancy increases the chances of early birth, low birth weight, or other complications for pregnant women in rural Sindh.

  Recruiting at 3 sites Aga Khan University · Matiari, Sindh and 2 other locations · NCT06957769

• Registry of outcomes and practices for extremely premature infants

  This study is trying to gather information about the health and care of extremely premature infants born at 22-23 weeks to help improve their treatment and outcomes.

  Recruiting at 59 sites The University of Texas Health Science Center, Houston · Birmingham, Alabama and 58 other locations · NCT05685745

• Biobank for studying pregnancy complications like preeclampsia and preterm birth

  This study collects samples and information from pregnant women to see if it can help identify the causes of complications like preeclampsia and preterm birth.

  Recruiting CHU de Quebec-Universite Laval · Québec · NCT02744365

• Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation

  This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.

  Recruiting at 2 sites Makerere University · Kampala and 1 other locations · NCT07844876

• Cervical stiffness test to help predict preterm birth in at-risk pregnant women

  A simple cervical stiffness test using the Pregnolia device is being studied to see if it can better identify women with threatened preterm labor who are likely to give birth soon.

  Recruiting Pregnolia AG · Prague · NCT07840235

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.