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Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour 2
ISRCTN ISRCTN05689407
DOI 10.1186/ISRCTN05689407
ClinicalTrials.gov identifier
EudraCT number
Public title Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour 2
Scientific title The effectiveness of immediate delivery after preterm prelabour rupture of membranes between 34 and 37 weeks compared to expectant management in a multicentre randomised controlled trial
Acronym PPROMEXIL 2
Serial number at source N/A
Study hypothesis Induction of labour in patients with preterm premature rupture of membranes (PPROM) between 34 and 37 weeks' gestation will reduce the incidence of neonatal sepsis. This advantage may outweigh the effects of prematurity (e.g. respiratory distress syndrome and hypoglycaemia)
Lay summary
Ethics approval Ethics committee of the University Hospital Maastricht
Study design Multicentre randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Preterm prelabour rupture of membranes
Participants - inclusion criteria 1. Women presenting with preterm prelabour rupture of the foetal membranes between 34+0 and 37+0 weeks' gestation and have not delivered within 24 hours after rupture of the foetal membranes
3. Women presenting with preterm prelabour rupture of foetal membranes after 26+0 weeks gestation who have not delivered at 34+0 weeks of gestation
4. Single and multiple gestations
5. Women with child in breech presentation can also be included
Participants - exclusion criteria 1. Monochorionic multiple pregnancies
2. Abnormal (non-reassuring) cardiotocogram (CTG)
3. Meconium stained amniotic fluid
4. Signs of intrauterine infection
5. Major foetal anomalies
6. Being in labour
7. Hemolytic anaemia, elevated liver enzymes and low platelet count (HELLP) syndrome
8. Severe pre-eclampsia
Anticipated start date 01/01/2010
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material Patient information sheet available in English/Dutch at http://www.studies-obsgyn.nl/ppromexil/docs/Pat%20informatie%20PPROMEXIL%20_%20engelse%20versie.doc Also available in French and Turkish on request.
Target number of participants 200
Interventions Participants will be randomised to induction of labour or expectant management.
If randomised for induction: same day or the day after. If randomised for expectant management: induction at 37 weeks' gestation.
Duration of treatment: Maximum 3 weeks. The follow-up will be done after 6 weeks, 6 months and 2 years.

The analysis will be done by intention to treat. Relative risks and 95% confidence intervals will be calculated for the relevant outcome measures. The analysis will be stratified for centre and parity. In case of equivalence between outcomes, the analysis will be repeated on a per protocol basis. Quality of life as well as pain scores will be analysed using repeated measures analysis of variance. Also a cost-effectiveness analysis will be done.
Primary outcome measure(s) Neonatal sepsis, measured immediately on discharge from hospital
Secondary outcome measure(s) 1. Respiratory distress syndrome (RDS)
2. Transient tachypnoea of the newborn
3. Asphyxia
4. Pneumothorax/pneumomediastinum
5. Late onset sepsis
6. Hypoglycaemia
7. Meconium aspiration syndrome
8. Necrotising enterocolitis (NEC)
9. Hyperbilirubinaemia
10. Intraventricular haemorrhage
11. Periventricular leucomalacia
12. Convulsions
13. Other neurological abnormalities and congenital abnormalities

Secondary maternal outcome measures:
1. Antepartum haemorrhage
2. Umbilical cord prolapse
3. Signs of chorioamnionitis
4. Maternal sepsis
5. Thrombo-embolic complications
6. Urinary tract infection treated with antibiotics
7. Signs of endometritis
8. Pneumonia
9. Anaphylactic shock
10. Haemolysis, Elevated Liver Enzymes, Low Platelets (HELLP) syndrome
11. Death
12. Incidence of instrumental deliveries
13. Maternal quality of life
14. Maternal intervention reference
15. Costs

Other outcomes:
Direct medical and non-medical costs, generated by maternal and neonatal resource utilisation during admission and post-discharge follow-up until 6 weeks after randomisation. The economic evaluation will integrate the primary clinical outcome and costs in a cost effectiveness analysis.

All outcomes will be measured immediately on discharge from hospital, and also 6 weeks and 6 months post-partum.
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Trial website
Publications
Contact name Ms  Jantien  van der Heyden
  Address De Run 4600
  City/town Veldhoven
  Zip/Postcode 5500 MB
  Country Netherlands
  Email j.vanderheyden@mmc.nl
Sponsor Academic Medical Centre (AMC) (Netherlands)
  Address Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 5669111
  Fax +31 (0)20 5664440
  Email info@studies-obsgyn.nl
Date applied 31/01/2010
Last edited 07/06/2010
Date ISRCTN assigned 07/06/2010
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