PERINATAL TRIALS REPORT

PT0536

Immediate delivery vs expectant care in women with preterm prelabour rupture of the membranes close to term - A randomised clinical trial

Plain Language Summary:      This proposal is for an adequately powered, well designed, randomised controlled trial to answer the clinical question: In women with preterm prelabour ruptured membranes between 34 weeks and 36 weeks 6 days gestation, is early planned birth associated with less neonatal and maternal morbidity. We have chosen a randomised clinical trial design as this is the accepted gold standard research method to compare health care interventions. Eligible women will be randomly assigned to early planned birth or expectant management. This trial will provide reliable, level 2 evidence, for clinicians to use to make decisions when faced with women with PPROM between 34-37 weeks gestation. In addition we shall perform an economic analysis to determine:
• the net impact of each intervention on hospital resources.
• which attributes of the treatment alternatives (such as time in hospital, risk of adverse outcomes, pain, continuity of care etc) are important to women.
• the relative importance of these attributes.
• the extent to which women are prepared to make trade-offs between attributes.

Trial status:                         Open to accrual

Date trial opened to accrual:    March 2004

Expected accrual period:         3-5 years

Trial Objective:

The primary aim of the project is to perform a randomised controlled trial to answer the clinical question:
In women with preterm prelabour ruptured membranes (PPROM) between 34 weeks and 36 weeks 6 days gestation is planned early delivery compared with expectant management associated with less neonatal and maternal morbidity?

The secondary aim is to perform an economic analysis of the outcomes to establish the economic impact of planned early delivery compared with
expectant management.

Type of administration:        Multi-centre International

Prinicipal Investigator/s:     Jonathan Morris

                                        Ph 61 2 9926 7013

                                        Email jmorris@med.usyd.edu.au

Contact Person/s:             As above

© IMPACT/PSANZ 2001