PERINATAL TRIALS REPORT

PTO384

Birth outcomes with Rofecoxib and Nifedipine

Plain Language Summary:      

Very early preterm birth (less than 28 weeks) has enormous consequences for families affected. This study will test a new combination of drugs (Rofecoxib and Nifedipine) for their ability to postpone delivery in women presenting with preterm labour less than 28 weeks. The ability to stop labour is important, but the main aim of treatment is to prevent neonatal deaths and handicap. Babies born to women enrolled in the study will be followed up for a period of one year to assess their outcomes.

Trial status:                        Open to accrual

Date trial opened to accrual: October 2003

Expected accrual period: Approximately 4 years

Trial Objective:

To assess whether Rofecoxib in combination with the calcium channel blocker Nifedipine is more effective than Nifedipine alone for producing pregnancy and improving neonatal outcomes in women presenting with very preterm labour (22-28 weeks).

Type of administration:       Multi- centre International

Principal Investigator/s:      Prof Warwick Giles

                                        Ph 61 2 49 214385

Contact Person/s:              Stephen Cole

                                        Ph 61 2 49214385 

                                        Email stevecole@bigpond.com

© IMPACT/PSANZ 2001