Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Christine Willekes
ORCID ID
Contact details
P. Debijelaan 25
Maastricht
6202 AZ
Netherlands
+31 (0)43 387 4768
cwi@sgyn.azm.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5521
Study information
Scientific title
Acronym
PPROMEXIL
Study hypothesis
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
Ethical approval received from the Medical Ethical Committee of the University Hospital Maastricht on the 3rd March 2006 (ref: MEC 05-240.5/fh).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Premature rupture of the membranes
Intervention
Induction of labour versus expectant management
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2007
Overall trial end date
01/01/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women with PPROM at a gestational age from 34 + 0/7 until 37 weeks who have given informed consent.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
520
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
P. Debijelaan 25
Maastricht
6202 AZ
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Sponsor details
PO Box 93245
Den Haag
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The 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
Results - basic reporting
Publication summary
1. 2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17617892
2. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22545024
3. 2014 economic analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/24392746
Publication citations
-
Protocol
van der Ham DP, Nijhuis JG, Mol BW, van Beek JJ, Opmeer BC, Bijlenga D, Groenewout M, Arabin B, Bloemenkamp KW, van Wijngaarden WJ, Wouters MG, Pernet PJ, Porath MM, Molkenboer JF, Derks JB, Kars MM, Scheepers HC, Weinans MJ, Woiski MD, Wildschut HI, Willekes C, Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial)., BMC Pregnancy Childbirth, 2007, 7, 11, doi: 10.1186/1471-2393-7-11.
-
Results
van der Ham DP, Vijgen SM, Nijhuis JG, van Beek JJ, Opmeer BC, Mulder AL, Moonen R, Groenewout M, van Pampus MG, Mantel GD, Bloemenkamp KW, van Wijngaarden WJ, Sikkema M, Haak MC, Pernet PJ, Porath M, Molkenboer JF, Kuppens S, Kwee A, Kars ME, Woiski M, Weinans MJ, Wildschut HI, Akerboom BM, Mol BW, Willekes C, , Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial., PLoS Med., 2012, 9, 4, e1001208, doi: 10.1371/journal.pmed.1001208.
-
Economic analysis results
Vijgen SM, van der Ham DP, Bijlenga D, van Beek JJ, Bloemenkamp KW, Kwee A, Groenewout M, Kars MM, Kuppens S, Mantel G, Molkenboer JF, Mulder AL, Nijhuis JG, Pernet PJ, Porath M, Woiski MD, Weinans MJ, van Wijngaarden WJ, Wildschut HI, Akerboom B, Sikkema JM, Willekes C, Mol BW, Opmeer BC, , Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)., Acta Obstet Gynecol Scand, 2014, 93, 4, 374-381, doi: 10.1111/aogs.12329.