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
Submission date
01/09/2006
Registration date
13/02/2007
Last edited
24/02/2015
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

Study website

Contact information

Dr Christine Willekes
Scientific

P. Debijelaan 25
Maastricht
6202 AZ
Netherlands

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePreterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour
Study acronymPPROMEXIL
Study objectivesThe 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) studiedPremature rupture of the membranes
InterventionInduction of labour versus expectant management
Intervention typeOther
Primary outcome measureNeonatal sepsis
Secondary outcome measures1. 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 date01/01/2007
Completion date01/01/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants520
Key inclusion criteriaPregnant women with PPROM at a gestational age from 34 + 0/7 until 37 weeks who have given informed consent.
Key exclusion criteria1. 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 enrolment01/01/2007
Date of final enrolment01/01/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

P. Debijelaan 25
Maastricht
6202 AZ
Netherlands

Sponsor information

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 logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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