A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women.
Completed
- Conditions
- Magnesium sulphate therapy, prior to very preterm birth.Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy
- Registration Number
- ACTRN12605000765628
- Lead Sponsor
- ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, The University of Adelaide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 51
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of any maternal adverse effects (clinical and self-assessed) during the magnesium sulphate infusion. This includes: arm discomfort with infusion, blurred vision, confusion/drowsiness, dizziness, headache, mild nausea/vomiting, mouth dryness, muscle weakness, palpitations, sweating, warmth/flushing, other reported side effects, tachycardia, respiratory depression.[Measured at 20 minutes and 60 minutes after the start of the infusion, and at completion of the infusion. ]
- Secondary Outcome Measures
Name Time Method Magnesium concentrations in cord blood at birth for the infant.[Measured at birth. ];Total amount of magnesium sulphate given prior to birth[Measured prior to birth. ];Cessation of treatment due to adverse effects attributed to the magnesium sulphate infusion. [Measured throughout the infusion. ];Adverse cardiorespiratory effects of the infusion (defined as a respiratory rate <16/minute, sdrop in diastolic blood pressure >15mmHg, cardiac arrest, respiratory arrest, maternal death)[Measured at 20 minutes and 60 minutes after the start of the infusion, and at completion of the infusion. ]