PPROMT Trial: Preterm Prelabour Rupture Of Membranes near Term
This trial is currently recruiting.
The PPROMT Trial is a randomised controlled trial assessing two forms of management, early planned birth versus expectant management, in women with ruptured membranes between 34 weeks and 36 weeks 6 days of pregnancy.
Prelabour rupture of the membranes (rupture of the membranes prior to the start of labour) occurs in 20% of all births. When this occurs at term there is good evidence that early delivery soon after the membranes rupture is associated with less infection in the mother and increased satisfaction of the mother compared with expectant management (waiting for labour to begin). The best management of women with preterm prelabour rupture of membranes (PPROM), rupture of the membranes before 37 weeks, is not known.
Preterm prelabour rupture of membranes (PPROM) is a common clinical problem, occuring in approximately 2% of all pregnancies and is the cause of 40% of all preterm births. The PPROMT trial will provide guidance to clinicians about the management of PPROM near term. The trial will also establish whether early planned delivery is associated with fewer health costs.
Eligibility criteria for trial entry
Women eligible for randomisation will be those between 34 and 36 weeks 6 days gestation, with singleton pregnancies, with PPROM. Women who rupture their membranes prior to 34 weeks gestation will become eligible at 34 weeks should they remain undelivered at 34 weeks gestation. Rupture of the membranes will be determined clinically and/or confirmed by a positive amnicator swab performed at the time of speculum examination.
| Chief Investigators: |
Prof Jonathan Morris, Dr Christine Roberts, Prof Caroline Crowther, Prof David Henderson-Smart |
| Local Clinical Trial Co-ordinator: | Ms Pat Ashwood |
| Local Email: | ppromt@adelaide.edu.au |
| Local Phone: Local Fax: |
61 8 8161 7767 61 8 8161 7652 |
| Local Address: | ARCH Discipline of Obstetrics and Gynaecology The University of Adelaide Women's and Children's Hospital King William Road North Adelaide South Australia 5006 |
| CENTRAL CO-ORDINATING OFFICE: |
Ms Kate Levett |
| Collaborating Centres: | Caboolture Hospital, Brisbane, Queensland Christchurch Women’s Hospital, New Zealand Gold Coast Hospital, Queensland Hornsby Ku-ring-gai Hospital New South Wales Ipswich Hospital, Queensland John Hunter Hospital, New South Wales King Edward Memorial Hospital, Perth, Western Australia Launceston General Hospital, Tasmania Liverpool Hospital, New South Wales Mater Mothers’ Hospital, Queensland Middlemore Hospital, New Zealand Nepean Hospital, New South Wales Ninewells Hospital, Dundee, New Zealand North Western Regional Hospital, Tasmania Palmerston North Hospital, New Zealand Royal Prince Alfred Hospital Women’s & Babies Hospital, New South Wales St George Hospital, New South Wales The Canberra Hospital, Australian Capital Territory Townsville Hospital, Queensland Westmead Hospital, New South Wales Wooongong Hospital, New South Wales Women's and Children's Hospital, South Australia |
References
Buchanan SL, Crowther CA, Levett KM, Middleton P, Morris J. Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome (Protocol). Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD004735. DOI: 10.1002/14651858.CD004735.pub2
Morris JM, Roberts CL, Crowther CA, Buchanan SL, Henderson-Smart DJ, Salkeld G. Protocol for the immediate delivery versus expectant care of women with preterm prelabour rupture of the membranes close to term (PPROMT) Trial [ISRCTN44485060]. BMC Pregnancy Childbirth. 2006 Mar 23;6:9.
Buchanan S, Crowther C, Morris J, Preterm prelabour rupture of the membranes: a survey of current practice. Aust N Z J Obstet Gynaecol. 2004 Oct;44(5):400-3
