Magnesium Sulphate for Preterm Birth (MASP Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Lene Huusom, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01492608
First received: December 11, 2011
Last updated: April 18, 2012
Last verified: April 2012

December 11, 2011
April 18, 2012
December 2011
December 2013   (final data collection date for primary outcome measure)
Moderate or severe cerebral palsy [ Time Frame: At 18 months of age ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01492608 on ClinicalTrials.gov Archive Site
  • Perinatal death [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 18 months ] [ Designated as safety issue: No ]
    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.
  • Blindness [ Time Frame: At 18 months of age ] [ Designated as safety issue: No ]
    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.
  • Apgar scores [ Time Frame: At 1 minute and 5 minutes after birth ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Magnesium Sulphate for Preterm Birth (MASP Study)
Administration of Antenatal Magnesium Sulphate for Prevention of Cerebral Palsy in Preterm Infants (MASP-STUDY)

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.

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 limited, and although clinical expression may change with time, this disability is accompanied with major personal and socioeconomic burdens. Preterm infants have increased risk of cerebral palsy, which is inversely correlated with gestational age at birth. Previous studies have indicated that magnesium sulphate may be neuroprotective for the preterm infant, when the drug is given to women prior to preterm birth. However, this benefit of antenatal magnesium sulphate was recently questioned by Trial Sequential Analysis (TSA), a statistical method that adjusts for risk of random error on published meta-analyses. TSA demonstrates that additional data are needed before accepting magnesium sulphate as evidence based therapy for women in preterm labour. Therefore we will close the gap by performing a new randomised clinical trial (RCT), which aims to assess whether magnesium sulphate for women prior to preterm birth can protect their children against cerebral palsy. The RCT will not individually have the power to detect a significant difference between magnesium and placebo. Instead, when the trial is completed, the results 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.

From Denmark, Sweden, Norway and Iceland 1,240 eligible women, who are at risk of preterm birth at 24 to 32 weeks of gestation, will be randomised to receive either intravenous magnesium sulphate or placebo. Randomisation will be performed blinded by computer generated random numbers.The children are followed up after 18 months of age by forwarding a standardized developmental questionnaire to the parents. If signs of cerebral palsy are suspected from the questionnaire, the children will be examined neurologically.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cerebral Palsy
Drug: Magnesium sulphate
Magnesium sulphate will be given as a loading dose of 5 g infused for 20-30 minutes, followed by a maintenance dose of 1 g per hour. Placebo will be given in identical appearing doses. The maintenance infusion will be continued until delivery appears, or for 24 hours if delivery does not occur or no longer is considered imminent. The infusion will be resumed when delivery is considered imminent again. Another loading dose of 5 g will be given if at least 6 hours has passed after infusion was stopped. The doses that are used in this project are similar to those used for prevention of eclampsia among women with severe preeclampsia.
Other Names:
  • Magnesium sulphate
  • Magnesium sulfat
  • Active Comparator: Magnesium sulphate
    Magnesium sulphate will be given as a loading dose of 5 g infused for 20-30 minutes, followed by a maintenance dose of 1 g per hour. Placebo will be given in identical appearing doses. The maintenance infusion will be continued until delivery appears, or for 24 hours if delivery does not occur or no longer is considered imminent. The infusion will be resumed when delivery is considered imminent again. Another loading dose of 5 g will be given if at least 6 hours has passed after infusion was stopped. The doses that are used in this project are similar to those used for prevention of eclampsia among women with severe preeclampsia.
    Intervention: Drug: Magnesium sulphate
  • Placebo Comparator: Natriumchlorid
    Intervention: Drug: Magnesium sulphate
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1240
June 2015
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact: Lene Huusom, MD ++45 6016 0405 lene.huusom@mail.dk
Contact: Niels Jørgen Secher, MD,Professor ++45 2622 8019 njsecher@dadlnet.dk
Iceland,   Sweden,   Denmark,   Norway
 
NCT01492608
EudraCT number 2011-000735-80, Projectnumber 2010-382
Yes
Lene Huusom, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Principal Investigator: Niels Jørgen Secher, MD,Professor Department of Gynecology and Obstetrics, Hvidovre Hospital, Copenhagen University Hospital, Denmark
Hvidovre University Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP