Status:
COMPLETED
Magnesium Sulphate for Preterm Birth (MASP Study)
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Cerebral Palsy
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Cerebral palsy consists of chronic and non-progressive clinical syndromes that are characterized by motor and postural dysfunction. In affected infants, voluntary movements become difficult and limite...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2019
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT01492608
Start Date
December 16 2011
End Date
August 12 2019
Last Update
August 14 2019
Active Locations (14)
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1
Hanne Trap Wolf
Hvidovre, Danmark, Denmark, 2650
2
Gynækologisk afdeling D
Odense, Fyn, Denmark, 5000
3
Gynækologisk-Obstetrisk Afdeling
Aalborg, Jylland, Denmark, 9100
4
Gynækologisk-obstetrisk afdeling Y
Aarhus, Jylland, Denmark, 8200