Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour
ISRCTN | ISRCTN29313500 |
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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
Contact information
Dr Christine Willekes
Scientific
Scientific
P. Debijelaan 25
Maastricht
6202 AZ
Netherlands
Phone | +31 (0)43 387 4768 |
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cwi@sgyn.azm.nl |
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P. Debijelaan 25
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
PO Box 93245
Den Haag
2509 AE
Netherlands
Website | http://www.zonmw.nl |
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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 | |
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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 |
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 |