The WISH Project - Working to Improve Survival and Health for babies born very preterm.

Not Applicable

Recruiting

• Conditions: cerebral palsy; perinatal mortality; preterm birth; Reproductive Health and Childbirth - Antenatal care

• Registration Number: ACTRN12611000636954
• Lead Sponsor: Professor Caroline Crowther

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

All women giving birth after 22 weeks' gestation (excluding known lethal congenital anomalies) and before 30 weeks' gestation at the participating hospitals.

Exclusion Criteria

Fetuses with known lethal congenital anomalies.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of women giving birth after 22 weeks' gestation (excluding known lethal congenital anomalies) and before 30 weeks' gestation receiving antenatal magnesium sulphate. This outcome will be obtained from medical records.[In 2011, 2012, and 2013.];Deaths prior to primary hospital discharge of babies born after 22 weeks gestation and before 30 weeks gestation in 2011, 2012, and 2013. This outcome will be obtained from medical records and the Australian and New Zealand Neonatal Network Data Collection.[In 2011, 2012, and 2013.];Cerebral palsy rate at up to three years' corrected age (in babies born alive after 22 weeks' gestation and before 30 weeks' gestation in 2011). This outcome data is obtained at standard paediatric assessment between the ages of 18 months and 3 years, and will be obtained by those centres involved in the WISH project from medical records.[Between 2013 and 2014.]

Secondary Outcome Measures

Name	Time	Method
Maternal adverse events related to administration of magnesium sulphate therapy (nausea, vomiting, respiratory depression, respiratory arrest, cardiac arrest, hypotension, tachycardia, admission to ICU, flushing, headache, diarrhoea, dizziness, drowsiness, need to be given calcium gluconate). These outcomes will be collected from medical records.[In 2011, 2012 and 2013.];Maternal adverse events sufficient to stop therapy. Possible adverse effects include: nausea, vomiting, respiratory depression, respiratory arrest, cardiac arrest, hypotension, tachycardia, admission to ICU, flushing, headache, diarrhoea, dizziness, drowsiness, need to be given calcium gluconate. These events will be assessed by the clinicians involved in the care of the women. The information will then be accessed from maternal case notes.[In 2011, 2012 and 2013.]