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Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour
DOI 10.1186/ISRCTN29313500
ClinicalTrials.gov identifier
EudraCT number
Public title Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour
Scientific title
Serial number at source 5521
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Ethical approval received from the Medical Ethical Committee of the University Hospital Maastricht on the 3rd March 2006 (ref: MEC 05-240.5/fh).
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Premature rupture of the membranes
Participants - inclusion criteria Pregnant women with PPROM at a gestational age from 34 + 0/7 until 37 weeks who have given informed consent.
Participants - exclusion criteria 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
Anticipated start date 01/01/2007
Anticipated end date 01/01/2010
Status of trial Completed
Patient information material
Target number of participants 520
Interventions Induction of labour versus expectant management
Primary outcome measure(s) Neonatal sepsis
Secondary outcome measure(s) 1. Maternal morbidity (chorioamnionitis/sepsis)
2. Respiratory Distress Syndrome (RDS)
3. Neonatal disease
4. Instrumental delivery rate
5. Quality of life and costs
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website http://www.studies-obsgyn/ppromexil
Publications 1. 2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17617892
2. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22545024
3. 2014 economic analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/24392746
Contact name Dr  Christine  Willekes
  Address P. Debijelaan 25
  City/town Maastricht
  Zip/Postcode 6202 AZ
  Country Netherlands
  Tel +31 (0)43 387 4768
  Fax +31 (0)43 387 4765
  Email cwi@sgyn.azm.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
  Address PO Box 93245
  City/town Den Haag
  Zip/Postcode 2509 AE
  Country Netherlands
  Sponsor website: http://www.zonmw.nl
Date applied 01/09/2006
Last edited 09/01/2014
Date ISRCTN assigned 13/02/2007
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