Magnesium Sulphate for Preterm Birth (MASP Study)

• Status: Completed
• Trial end date: 2019-08-12
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Treatments: Magnesium Sulfate

Criteria

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