NCT01492608

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

December 16, 2011

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

7.7 years

First QC Date

December 11, 2011

Last Update Submit

August 13, 2019

Conditions

Cerebral Palsy

Keywords

magnesium sulphatepreterm birthcerebral palsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Perinatal death

    From date of randomization until the date of death from any cause, assessed up to 18 months

  • Composite outcome of outcome 1 and 2 (moderate-severe cerebral palsy and perinatal death)

    At 18 months of age

  • Blindness

    At 18 months of age

  • Apgar scores

    At 1 minute and 5 minutes after birth

Other Outcomes (13)

  • Cranial ultrasound findings

    Assessed up to 18 months of age

  • Resuscitation in delivery room

    First hour of life

  • Neonatal convulsions

    Assessed up to 18 months of age

  • +10 more other outcomes

Study Arms (2)

Magnesium sulphate

ACTIVE COMPARATOR

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

Natriumchlorid

PLACEBO COMPARATOR

Placebo and the active drug (Magnesium sulphate) will be administered identically (same loading and maintenance dose for the same period of time).

Drug: Magnesium sulphate

Interventions

Magnesium sulphateDRUG

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.

Also known as: Magnesium sulfat
Magnesium sulphateNatriumchlorid

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hanne Trap Wolf

Hvidovre, Danmark, 2650, Denmark

Location

Gynækologisk afdeling D

Odense, Fyn, 5000, Denmark

Location

Gynækologisk-Obstetrisk Afdeling

Aalborg, Jylland, 9100, Denmark

Location

Gynækologisk-obstetrisk afdeling Y

Aarhus, Jylland, 8200, Denmark

Location

Gynækologisk obstetrisk Afdeling

Esbjerg, Jylland, 6700, Denmark

Location

Gynækologisk-obstetrisk afd.

Kolding, Jylland, 6000, Denmark

Location

Gynækologisk obstetrisk afdeling

Randers, Jylland, 8930, Denmark

Location

Gynækologisk-obstetrisk afd.

Silkeborg, Jylland, 8600, Denmark

Location

Kvindeafdeling Y

Viborg, Jylland, 8800, Denmark

Location

Obstetrisk Klinik

Copenhagen, Region Sjælland, 2100, Denmark

Location

Gynækologisk Obstetrisk afdeling

Herlev, Region Sjælland, Denmark

Location

Gynækologisk-Obstetrisk Afdeling

Hillerød, Region Sjælland, 3400, Denmark

Location

Gynækologisk Obstetrisk afdeling

Holbæk, Region Sjælland, 4300, Denmark

Location

Gynækologisk-obstetrisk afdeling

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (1)

  • 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. No abstract available.

    PMID: 21197681BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyPremature Birth

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Lene Huusom, MD

    Department of Gynecology and Obstetrics, Hvidovre Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 11, 2011

First Posted

December 15, 2011

Study Start

December 16, 2011

Primary Completion

August 12, 2019

Study Completion

August 12, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

DK(14)