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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
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Drug: Magnesium sulphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Administration of Antenatal Magnesium Sulphate for Prevention of Cerebral Palsy in Preterm Infants (MASP-STUDY)

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1240
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Placebo Comparator: Natriumchlorid 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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492608

Contacts
Contact: Lene Huusom, MD ++45 6016 0405 lene.huusom@mail.dk
Contact: Niels Jørgen Secher, MD,Professor ++45 2622 8019 njsecher@dadlnet.dk

Locations
Denmark
Gynækologisk afdeling D Recruiting
Odense, Fyn, Denmark, 5000
Contact: Bodil Andersen, MD    ++45 6611 3333    bodilandersen@dadlnet.dk   
Principal Investigator: Bodil Andersen, MD         
Gynækologisk-obstetrisk afdeling Y Recruiting
Aarhus, Jylland, Denmark, 8200
Contact: Jannie Salvig, MD    ++45 8949 6300    jannsalv@rm.dk   
Principal Investigator: Jannie Salvig, MD         
Gynækologisk obstetrisk Afdeling Recruiting
Esbjerg, Jylland, Denmark, 6700
Contact: Troels Kragsig Thomsen, MD    ++45 7918 2714    troels.kragsig.thomsen2@svs.regionsyddanmark.dk   
Principal Investigator: Troels Kragsig Thomsen, MD         
Gynækologisk-obstetrisk afd. Recruiting
Kolding, Jylland, Denmark, 6000
Contact: Annette Vind Olesen, MD    ++45 7636 2000    annette.wind.olesen@slb.regionsyddanmark.dk   
Principal Investigator: Annette Vind Olesen, MD         
Gynækologisk obstetrisk afdeling Recruiting
Randers, Jylland, Denmark, 8930
Contact: Susanne Ledertoug, MD    ++45 7842 1060    susalede@rm.dk   
Principal Investigator: Susanne Ledertoug, MD         
Gynækologisk-obstetrisk afd. Recruiting
Silkeborg, Jylland, Denmark, 8600
Contact: Jane Boris, MD    ++45 8722 2555    janebori@rm.dk   
Principal Investigator: Jane Boris, MD         
Kvindeafdeling Y Recruiting
Viborg, Jylland, Denmark, 8800
Contact: Linn Helleland, MD    ++45 7844 5746    Linn.Elisabeth.Helleland@Viborg.RM.dk   
Principal Investigator: Linn Helleland, MD         
Gynækologisk-Obstetrisk Afdeling Recruiting
Ålborg, Jylland, Denmark, 9100
Contact: Margrethe Møller, MD    ++435 9932 1111    margr@dadlnet.dk   
Principal Investigator: Margrethe Møller, MD         
Obstetrisk Klinik Recruiting
Copenhagen, Sjælland, Denmark, 2100
Contact: Heidi Sharif, MD    ++45 3545 3545    heidi_sharif@yahoo.dk   
Principal Investigator: Heidi Sharif, MD         
Gynækologisk Obstetrisk afdeling Recruiting
Herlev, Sjælland, Denmark
Contact: Henriette Jensen, MD    ++45 3868 3868    henriettehjensen@yahoo.dk   
Principal Investigator: Henriette Jensen, MD         
Gynækologisk-Obstetrisk Afdeling Recruiting
Hillerød, Sjælland, Denmark, 3400
Contact: Anne Cathrine Shalmi, MD    ++45 4829 4829    ash@noh.regionh.dk   
Principal Investigator: Anne Cathrine Shalmi, MD         
Gynækologisk Obstetrisk afdeling Recruiting
Holbæk, Sjælland, Denmark, 4300
Contact: Anna Aabakke, MD    ++45 5948 4252    anae@regionsjaelland.dk   
Principal Investigator: Anna Aabakke, MD         
Gynækologisk Obstetrisk afdeling Recruiting
Hvidovre, Sjælland, Denmark, 2650
Contact: Lene Huusom, MD    ++45 60160405    lene.huusom@mail.dk   
Principal Investigator: Lene Huusom, MD         
Gynækologisk-obstetrisk afdeling Recruiting
Næstved, Sjælland, Denmark, 4700
Contact: Lisbeth Jønsson, MD    ++45 5651 4082    ljos@regionsjaelland.dk   
Principal Investigator: Lisbeth Jønsson, MD         
Gynækologisk-obstetrisk afdeling Recruiting
Roskilde, Sjælland, Denmark, 4000
Contact: Jens Lyndrup, MD    ++45 4632 3200    jlyndrup@dadlnet.dk   
Principal Investigator: Jens Lyndrup, MD         
Iceland
Department of Obstetrics and Gynecology Not yet recruiting
Reykjavik, Iceland, IS-101
Contact: Reynir Geirsson, MD    +354 543 1000    geirsson.acta@landspitali.is   
Principal Investigator: Reynir Geirsson, MD         
Norway
Kvinne-barn senteret Not yet recruiting
Tronheim, Norway, Postboks 3250
Contact: Bjørn Backe, MD    +47 815 55 850    bjorn.backe@ntnu.no   
Principal Investigator: Bjørn Backe, MD         
Sweden
Dept. of Obstetrics and Gynecology Not yet recruiting
Malmø, Sweden, S-20502
Contact: Per Olufsson, MD    ++46 4033 1000    Per.Olofsson@med.lu.se   
Principal Investigator: Per Olufsson, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Niels Jørgen Secher, MD,Professor Department of Gynecology and Obstetrics, Hvidovre Hospital, Copenhagen University Hospital, Denmark
  More Information

Publications:
Responsible Party: Lene Huusom, Medical Doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01492608     History of Changes
Other Study ID Numbers: EudraCT number 2011-000735-80, Projectnumber 2010-382
Study First Received: December 11, 2011
Last Updated: April 18, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:
magnesium sulphate
preterm birth
cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 25, 2014