PERINATAL TRIALS REPORT
PT0533
Randomised controlled trial of Nifedipine for maintenance tocolysis
Plain Language Summary: Prematurity is the leading cause of death in the newborn and a major cause of disability and cerebral palsy in children. About two thirds of preterm births result from spontaneous preterm labour and about one third are due to other pregnancy problems eg pre-clampsia. Women in threatened preterm labour are currently treated with nifedipine to delay delivery for 48 hours and allow administration of corticosteroids. Corticosteroid administration has been shown to reduce neonatal deaths and other major complications in the preterm baby. The proposed study will investigate whether continued treatment with nifedipine after the initial 48 hours, will further delay delivery in women who are at high risk of preterm delivery. The study will be a double-blind placebo controlled trial carried out in Aukland. In addition, the study will determine whether maintenance nifdipine treatment reduces the length of newborn hospital stay and hospital costs.
Trial status: Open to accrual
Date trial opened to accrual: September 2003
Expected accrual period: 3 years
Trial Objective:
To see if continued maintenance nifedipine prolongs pregnancy by 7 days.
Type of administration: Multi-centre national
Prinicipal Investigator/s:
Dr Emma Parry
Contact Person/s: As above
© IMPACT/PSANZ 2001