Cerebral Palsy Clinical Trial
— MASPOfficial title:
Administration of Antenatal Magnesium Sulphate for Prevention of Cerebral Palsy and Death in Preterm Infants (MASP-STUDY)
Verified date | August 2019 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to assess whether magnesium sulphate for women at risk of preterm birth can protect their children against cerebral palsy. The results from this randomised controlled trial will be added to the previous meta-analysis to obtain firm evidence for magnesium sulphate as a neuroprotector, and determine whether it should be used as standard therapy for women in preterm birth.
Status | Completed |
Enrollment | 560 |
Est. completion date | August 12, 2019 |
Est. primary completion date | August 12, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Gestational age 24+0-31+6 weeks - Singletons or twins - Preterm rupture of membranes at 24+0-31+6 weeks with contractions and expected birth within 2-24 hours - Preterm contractions and expected birth within 2-24 hours - Anticipated delivery within 2-24 hours of other reasons (due to for example fetal growth restriction) - Age 18 years at inclusion Exclusion Criteria: - Major fetal abnormalities or fetal death. (Major fetal abnormalities are chromosome abnormalities, myelomeningocele and cerebral abnormalities that gives neurological handicaps) - Maternal contraindication to magnesium sulphate (for example pulmonary disorders, kidney diseases with creatinin > 100, myasthenia gravis, atrioventricular block, treatment with aminoglycosides) - Magnesium sulphate given for other reasons (for example for prevention of eclampsia) - Patients who do not speak and understand Danish - Allergies towards magnesium sulphate |
Country | Name | City | State |
---|---|---|---|
Denmark | Gynækologisk-Obstetrisk Afdeling | Aalborg | Jylland |
Denmark | Gynækologisk-obstetrisk afdeling Y | Aarhus | Jylland |
Denmark | Obstetrisk Klinik | Copenhagen | Sjælland |
Denmark | Gynækologisk obstetrisk Afdeling | Esbjerg | Jylland |
Denmark | Gynækologisk Obstetrisk afdeling | Herlev | Sjælland |
Denmark | Gynækologisk-Obstetrisk Afdeling | Hillerød | Sjælland |
Denmark | Gynækologisk Obstetrisk afdeling | Holbæk | Sjælland |
Denmark | Hanne Trap Wolf | Hvidovre | Danmark |
Denmark | Gynækologisk-obstetrisk afd. | Kolding | Jylland |
Denmark | Gynækologisk-obstetrisk afdeling | Næstved | Sjælland |
Denmark | Gynækologisk afdeling D | Odense | Fyn |
Denmark | Gynækologisk obstetrisk afdeling | Randers | Jylland |
Denmark | Gynækologisk-obstetrisk afd. | Silkeborg | Jylland |
Denmark | Kvindeafdeling Y | Viborg | Jylland |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Huusom LD, Secher NJ, Pryds O, Whitfield K, Gluud C, Brok J. Antenatal magnesium sulphate may prevent cerebral palsy in preterm infants--but are we convinced? Evaluation of an apparently conclusive meta-analysis with trial sequential analysis. BJOG. 2011 Jan;118(1):1-5. doi: 10.1111/j.1471-0528.2010.02782.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cranial ultrasound findings | Frequency of intraventricular hemorrhage and periventricular leukomalacia in the two groups ((intervention and placebo group). | Assessed up to 18 months of age | |
Other | Resuscitation in delivery room | Mode of resuscitation in delivery room in the two groups (intervention and placebo group) | First hour of life | |
Other | Neonatal convulsions | Clinically verified convulsions during first neonatal admission. | Assessed up to 18 months of age | |
Other | Use of respiratory support | Endotracheal ventilation or continuous positive airways pressure, or both during first neonatal admission. | Assessed up to 18 months of age | |
Other | Bronchopulmonary dysplasia (BPD) | Mild BPD: Need for continuous, supplemental oxygen at = 28 days but not at 36-week postmenstrual age. Moderate BPD: Need for continuous, supplemental oxygen at 28 days, in addition to supplemental oxygen at =30% at 36-week postmenstrual age. Severe BPD: Need for continuous, supplemental oxygen at 28 days and, at 36-week postmenstrual age, the need for mechanical ventilation and/or oxygen >30% |
Assessed up to 18 months of age | |
Other | Hypotension | Need of volume therapy or vasopressors during first neonatal admission. | Assessed up to 18 months of age | |
Other | Length of neonatal hospitalization | Length of the neonatal hospitalization measured in days. From time of birth to discharge after first neonatal admisson or until death. | Assessed up to 18 months of age | |
Other | Retinopathy of prematurity | Retinopathy of prematurity stage 1-5 | At 18 months of age | |
Other | Patent ductus arteriosus | Ultrasound verified patent ductus arteriosus | At 18 months of age | |
Other | Necrotizing enterocolitis | Defined according to Bell's critiria | Assessed up to 18 months of age | |
Other | Cerebral palsy | Mild (GMFCS level I), moderate (II-III), severe (IV-V), any | At 18 months of age | |
Other | Blood transfusion | Number of children receiving bood transfusion during first admission | Assessed up to 18 months of age | |
Other | Deafness | One or both ears | At 18 months of age | |
Primary | Moderate or severe cerebral palsy | The difference in the number of children with moderate or severe cerebral palsy at 18 months of age, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth. | At 18 months of age | |
Secondary | Perinatal death | The difference in the number of children with perinatal death, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth. | From date of randomization until the date of death from any cause, assessed up to 18 months | |
Secondary | Composite outcome of outcome 1 and 2 (moderate-severe cerebral palsy and perinatal death) | Frequency of the composite outcome in the two groups ((intervention and placebo group) | At 18 months of age | |
Secondary | Blindness | The difference in the number of children with blindness at 18 months of age, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth. | At 18 months of age | |
Secondary | Apgar scores | The difference in apgar scores in the group of children, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth. | At 1 minute and 5 minutes after birth |
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