Contact information
Type
Scientific
Primary contact
Ms Jantien van der Heyden
ORCID ID
Contact details
De Run 4600
Veldhoven
5500 MB
Netherlands
-
j.vanderheyden@mmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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)
Ethics approval
Ethics committee of the University Hospital Maastricht
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
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.
Condition
Preterm prelabour rupture of membranes
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Neonatal sepsis, measured immediately on discharge from hospital
Secondary outcome measures
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.
Overall trial start date
01/01/2010
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant 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
Recruitment start date
01/01/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
De Run 4600
Veldhoven
5500 MB
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5669111
info@studies-obsgyn.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/24862166