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
Secondary identifying numbers	5521

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Neonatal sepsis
Secondary outcome measures	1. Maternal morbidity (chorioamnionitis/sepsis) 2. Respiratory Distress Syndrome (RDS) 3. Neonatal disease 4. Instrumental delivery rate 5. Quality of life and costs
Overall study start date	01/01/2007
Completion date	01/01/2010

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation

PO Box 93245
Den Haag
2509 AE
Netherlands

Website	http://www.zonmw.nl
"ROR"	https://ror.org/01yaj9a77

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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