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

ISRCTN	ISRCTN29313500
DOI	https://doi.org/10.1186/ISRCTN29313500
Protocol serial number	5521
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Christine Willekes
Scientific

P. Debijelaan 25
Maastricht
6202 AZ
Netherlands

Phone	+31 (0)43 387 4768
Email	cwi@sgyn.azm.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour
Study acronym	PPROMEXIL
Study objectives	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.
Ethics approval(s)	Medical Ethical Committee of the University Hospital Maastricht, 03/03/2006, ref: MEC 05-240.5/fh
Health condition(s) or problem(s) studied	Premature rupture of the membranes
Intervention	Induction of labour versus expectant management
Intervention type	Other
Primary outcome measure(s)	Neonatal sepsis
Key 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
Completion date	01/01/2010

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	520
Key inclusion criteria	Pregnant women with PPROM at a gestational age from 34 + 0/7 until 37 weeks who have given informed consent.
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2010

P. Debijelaan 25

Maastricht
6202 AZ
Netherlands

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2012		Yes	No
Results article	economic analysis results	01/04/2014		Yes	No
Protocol article	protocol	06/07/2007		Yes	No
Other publications	secondary analysis	01/09/2014		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes