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ISRCTN
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ISRCTN29313500
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DOI
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10.1186/ISRCTN29313500
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour
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Scientific title
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Acronym
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PPROMEXIL
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Serial number at source
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5521
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Study hypothesis
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The aim of this study is to solve the dilemma for the obstetric gynaecologist regarding the optimal treatment of women with Preterm Premature Rupture Of the Membranes (PPROM) after 34 weeks of gestation. Therefore, we will compare the effectiveness of induction of labour after PPROM between 34 and 37 weeks gestation compared to expectant monitoring on neonatal infection. Also, cost effectiveness and quality of life is measured in both treatment arms and compared.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethical approval received from the Medical Ethical Committee of the University Hospital Maastricht on the 3rd March 2006 (ref: MEC 05-240.5/fh).
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Premature rupture of the membranes
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Participants - inclusion criteria
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Pregnant women with PPROM at a gestational age from 34 + 0/7 until 37 weeks who have given informed consent.
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Participants - exclusion criteria
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1. Foetal distress
2. Major foetal anomalies
3. Meconium stained amniotic fluid
4. Maternal infection at entry
5. Monochorionic Diamniotic (MCDA) multiple pregnancy
6. Multiple pregnancy, first child breech presentation
7. Previous caesarean section
8. Diabetes mellitus (defined as use of insulin)
9. Renal disease (inluding Systemic Lupus Erythematosus [SLE])
10. Seropositive for Human Immunodeficiency Virus (HIV)
11. Haemolysis, Elevated Liver, Low Platelet (HELLP)/severe pre-eclampsia
12. Oliguria less than 500 ml/24 hours
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Anticipated start date
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01/01/2007
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Anticipated end date
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01/01/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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520
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Interventions
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Induction of labour versus expectant management
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Primary outcome measure(s)
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Neonatal sepsis
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Secondary outcome measure(s)
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1. Maternal morbidity (chorioamnionitis/sepsis)
2. Respiratory Distress Syndrome (RDS)
3. Neonatal disease
4. Instrumental delivery rate
5. Quality of life and costs
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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http://www.studies-obsgyn/ppromexil
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Publications
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1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17617892
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22545024
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Contact name
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Dr
Christine
Willekes
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Address
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P. Debijelaan 25
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City/town
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Maastricht
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Zip/Postcode
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6202 AZ
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Country
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Netherlands
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Tel
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+31 (0)43 387 4768
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Fax
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+31 (0)43 387 4765
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Email
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cwi@sgyn.azm.nl
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Sponsor
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Address
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PO Box 93245
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City/town
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Den Haag
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Sponsor website:
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http://www.zonmw.nl
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Date applied
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01/09/2006
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Last edited
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03/08/2012
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Date ISRCTN assigned
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13/02/2007
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