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Magnesium Sulphate for Preterm Birth (MASP Study)

NCT01492608 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2019-08-14

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

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.

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Lene Huusom, MD · Department of Gynecology and Obstetrics, Hvidovre Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-16
Primary Completion
2019-08-12
Completion
2019-08-12

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01492608 on ClinicalTrials.gov