O60 NULL NULL
Conditions
Interventions
None listed
Sponsors
UNIVERSIDAD DE TORONTO
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Women who have previously received a full course of antenatal corticosteroids 14-21 days before and who continue to have an increased risk of preterm delivery. • Gestational age greater than or equal to 25 weeks and less than or equal to 32 full weeks of gestation (gestational age will be determined by the clinician based on menstrual history and 1st trimester ultrasound if one is available). • All fetuses must be alive at the time of randomization. However, in multiple gestations, if it were believed that any fetus had died before week 13, that fetus will not be considered part of the pregnancy for the purpose of this study,
Exclusion criteria
Exclusion criteria: • Women who require chronic doses of corticosteroids secondary to specific medical situations (eg: systemic lupus erythematosus, congenital adrenal hyperplasia, and severe asthma) • Women with contraindication to corticosteroids. • Women with clinical evidence of chorioamnionitis (temperature 38 ° C). • Known congenital lethal malformation (eg: anencephaly) in any of the fetuses • First batch of antenatal corticosteroids received prior to week 23 • Previous participation in the MACS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| defined as one or more of the following cases: 1. Respiratory Distress Syndrome 2. Bronchopulmonary dysplasia 3. Grade IV intraventricular hemorrhage 4. Periventricular cysts 5. Necrotizing enterocolitis NAME OF THE RESULT: Significant Neonatal Morbidity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 24 hours;defined as antenatal, or postnatal, death during the first 28 days of life or before hospital discharge, which occurred later. NAME OF THE RESULT: Perinatal or Neonatal Mortality PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| defined as one or more of the following cases: 1. Respiratory Distress Syndrome 2. Bronchopulmonary dysplasia 3. Grade IV intraventricular hemorrhage 4. Periventricular cysts 5. Necrotizing enterocolitis NAME OF THE RESULT: Significant Neonatal Morbidity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 24 hours;defined as antenatal, or postnatal, death during the first 28 days of life or before hospital discharge, which occurred later. NAME OF THE RESULT: Perinatal or Neonatal Mortality PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 28 days;defined as one or more of the following cases 1. Death 2. Cerebral palsy 3. BDSI-II (MDI) <70 NAME OF THE RESULT: Death or neurological deficit at 18-24 months of life PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 18-24 months of life;Measurement of weight, length and cranial circumference at birth NAME OF THE RESULT: weight, length and cranial circumference at birth PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: at birth;Clinical signs of infection and one or more of the following elements: positive culture of blood, cerebrospinal fluid, or lung tissue at necropsy; a positive Gram stain in cerebrospinal fluid, a chest radiograph compatible with pneumonia; or a histological diagnosis of pneumonia at necropsy NAME OF THE RESULT: Neonatal infection PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 28 days;Retinopathy of prematurity, diagnosed in one or both eyes. NAME OF THE RESULT: Retinopathy of prematurity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 28 days;Duration of stay in the neonatal intensive care unit and duration of use of ventilation with tubing. NAME OF THE RESULT: Duration of | — |
Countries
Peru
Outcome results
None listed