Pregnancies at increased risk of preterm birth Pregnancy and Childbirth Preterm birth
Conditions
Interventions
1. Betamethasone (Celestone Soluspan):
Two doses, 12mg per dose, given IntraMuscular (IM) 24 hours apart - if risk of preterm birth continues, this will be repeated every 14 days until 33 completed we
if risk of preterm birth continues, this will be repeated every 14 days until 33 completed weeks gestation.
The contact for scientific queries for MACS-5 is:
Dr Elizabeth Vagi Asztalos
Sunnybrook Hea
Sponsors
University of Toronto Faculty of Medicine Research Office (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who have previously received one completed course of ACS, 14 to 21 days ago, and continue to be at increased risk of preterm birth 2. Women of child-bearing age; their children from birth to 24 months corrected gestational age, either sex 3. Gestational age more than or equal to 26 weeks of gestation and less than 30 completed weeks 4. Women at 25 to 32 weeks gestation who remain at increased risk of preterm birth 14 to 21 days after a single course of antenatal corticosteroids
Exclusion criteria
Exclusion criteria: 1. Women requiring chronic doses of corticosteroids secondary to medical conditions 2. Women with a contraindication to corticoosteroids 3. Women with clinical evidence of chorioamnionitis (temperature more than or equal to 38°C) 4. Known lethal congenital anomaly (e.g. anencephaly) in any fetus 5. First course of ACS given prior to 23 weeks 6. Previous participation in MACS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perinatal or neonatal mortality or serious neonatal morbidity (stillbirth or neonatal death; one or more of Respiratory Distress Syndrome [RDS], BronchoPulmonary Dysplasia [BPD], IntraVentricular Haemorrhage [IVH] grade III or IV, Cystic Peri-Ventricular Leucomalacia [PVL], Necrotizing EnteroColitis [NEC]) during the first 28 days of life or prior to hospital discharge, whichever is later. MACS-5: Primary outcome measured at five years of age of a child consisting of: 1. Death or impaired neuromotor (non-ambulatory cerebral palsy) or neurosensory function (blindness, deafness or need for visual or hearing aids), assessed by clinical exam 2. Abnormal attention, memory, or behaviour, assessed by parent administered questionnaire incorporating the Child Behaviour Checklist (1½ to 5) and the Behaviour Rating Inventory of Executive Function (Preschool version) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Death or neurological impairment (one or more of death, Cerebral Palsy [CP], Bayley Scales of Infant Development [BSID-II], Mental Development Index [MDI] less than 70). 2. Time point of measurement 18-24 months corrected gestational age. MACS-5: Measured at 5 years of age: 1. Measure of growth and blood pressure (height, weight, head circumference, systolic and diastolic Blood Pressure [BP]); assessed by clinical exam. 2. For children in English-speaking centres: intelligence and visual motor, visual spatial, and language skills; assessed by certified psychologists using the Weschler Preschool and Primary Intelligence Scale for Children - Third Edition (WPSSI-III), The Developmental Test of Visual Motor Integration - Fifth Edition (VMI) and Peabody Picture Vocabulary Test - Third Edition (PPVT-III). | — |
Countries
Argentina, Bolivia, Brazil, Canada, Chile, China, Colombia, Denmark, Germany, Hungary, Israel, Jordan, Netherlands, Peru, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States of America
Outcome results
None listed