A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women.

A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women for the prevention of side effects.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000765628

Enrollment

Registered

2005-11-25

Start date

2006-02-21

Completion date

2012-04-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This randomised clinical trial will assess whether a slower, compared with the standard infusion rate of the loading dose of magnesium sulphate, given to women at risk of very preterm birth at less than 30 weeks gestation for fetal neuroprotection, is effective in reducing maternal adverse effects of treatment.

Interventions

Women recruited will receive a magnesium sulphate intravenous infusion for 24 hours or until they give birth (whichever is the shorter) and will be randomised to different rates of administration of the intravenous loading infusion. 4 g magnesium sulphate over 60 minutes followed by 1 g per hour versus 4 g magnesium sulphate over 20 minutes followed by 1 g per hour.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Women who are now recommended magnesium sulphate as per the National Clinical Practice Guidelines, and the South Australian Perinatal Practice Guidelines: a gestational age of less than 30 weeks where birth is planned or definitely expected within 24 hours. The women must have a singleton or twin pregnancy.

Exclusion criteria

1) Women with the following contraindications to magnesium sulphate: absent patellar reflexes, hypocalcaemia, respiratory rate < 16/minute, renal failure, urine output < 100mls during the last 4 hours; 2) Women who are in the second stage of labour; 3) Women who have already been given magnesium sulphate therapy in this pregnancy.

Outcome results