Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour 2

ISRCTN	ISRCTN05689407
DOI	https://doi.org/10.1186/ISRCTN05689407
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Submission date: 31/01/2010
Registration date: 07/06/2010
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Jantien van der Heyden
Scientific

De Run 4600
Veldhoven
5500 MB
Netherlands

Email	j.vanderheyden@mmc.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PPROMEXIL 2
Study objectives	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(s)	Ethics committee of the University Hospital Maastricht
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Neonatal sepsis, measured immediately on discharge from hospital
Key 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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	200
Total final enrolment	195
Key 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
Key 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
Date of first enrolment	01/01/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

De Run 4600

Veldhoven
5500 MB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012	29/12/2020	Yes	No
Other publications	secondary analysis	01/09/2014		Yes	No
Other publications	prediction model development	01/05/2014	29/12/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.