Preterm Premature Rupture Of Membranes between 34 and 37 weeks: EXpectant management versus Induction of Labour 2
| ISRCTN | ISRCTN05689407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05689407 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2010
- Registration date
- 07/06/2010
- Last edited
- 29/12/2020
- 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
Ms Jantien van der Heyden
Scientific
Scientific
De Run 4600
Veldhoven
5500 MB
Netherlands
| j.vanderheyden@mmc.nl |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information sheet available in English/Dutch at http://www.studies-obsgyn.nl/ppromexil/docs/Pat%20informatie%20PPROMEXIL%20_%20engelse%20versie.doc Also available in French and Turkish on request. |
| Scientific title | The effectiveness of immediate delivery after preterm prelabour rupture of membranes between 34 and 37 weeks compared to expectant management in a multicentre randomised controlled trial |
| Study acronym | PPROMEXIL 2 |
| Study objectives | Induction of labour in patients with preterm premature rupture of membranes (PPROM) between 34 and 37 weeks' gestation will reduce the incidence of neonatal sepsis. This advantage may outweigh the effects of prematurity (e.g. respiratory distress syndrome and hypoglycaemia) |
| Ethics approval(s) | Ethics committee of the University Hospital Maastricht |
| Health condition(s) or problem(s) studied | Preterm prelabour rupture of membranes |
| Intervention | Participants will be randomised to induction of labour or expectant management. If randomised for induction: same day or the day after. If randomised for expectant management: induction at 37 weeks' gestation. Duration of treatment: Maximum 3 weeks. The follow-up will be done after 6 weeks, 6 months and 2 years. The analysis will be done by intention to treat. Relative risks and 95% confidence intervals will be calculated for the relevant outcome measures. The analysis will be stratified for centre and parity. In case of equivalence between outcomes, the analysis will be repeated on a per protocol basis. Quality of life as well as pain scores will be analysed using repeated measures analysis of variance. Also a cost-effectiveness analysis will be done. |
| Intervention type | Other |
| Primary outcome measure | Neonatal sepsis, measured immediately on discharge from hospital |
| Secondary outcome measures | 1. Respiratory distress syndrome (RDS) 2. Transient tachypnoea of the newborn 3. Asphyxia 4. Pneumothorax/pneumomediastinum 5. Late onset sepsis 6. Hypoglycaemia 7. Meconium aspiration syndrome 8. Necrotising enterocolitis (NEC) 9. Hyperbilirubinaemia 10. Intraventricular haemorrhage 11. Periventricular leucomalacia 12. Convulsions 13. Other neurological abnormalities and congenital abnormalities Secondary maternal outcome measures: 1. Antepartum haemorrhage 2. Umbilical cord prolapse 3. Signs of chorioamnionitis 4. Maternal sepsis 5. Thrombo-embolic complications 6. Urinary tract infection treated with antibiotics 7. Signs of endometritis 8. Pneumonia 9. Anaphylactic shock 10. Haemolysis, Elevated Liver Enzymes, Low Platelets (HELLP) syndrome 11. Death 12. Incidence of instrumental deliveries 13. Maternal quality of life 14. Maternal intervention reference 15. Costs Other outcomes: Direct medical and non-medical costs, generated by maternal and neonatal resource utilisation during admission and post-discharge follow-up until 6 weeks after randomisation. The economic evaluation will integrate the primary clinical outcome and costs in a cost effectiveness analysis. All outcomes will be measured immediately on discharge from hospital, and also 6 weeks and 6 months post-partum. |
| Overall study start date | 01/01/2010 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 195 |
| Key inclusion criteria | 1. Women presenting with preterm prelabour rupture of the foetal membranes between 34+0 and 37+0 weeks' gestation and have not delivered within 24 hours after rupture of the foetal membranes 3. Women presenting with preterm prelabour rupture of foetal membranes after 26+0 weeks gestation who have not delivered at 34+0 weeks of gestation 4. Single and multiple gestations 5. Women with child in breech presentation can also be included |
| Key exclusion criteria | 1. Monochorionic multiple pregnancies 2. Abnormal (non-reassuring) cardiotocogram (CTG) 3. Meconium stained amniotic fluid 4. Signs of intrauterine infection 5. Major foetal anomalies 6. Being in labour 7. Hemolytic anaemia, elevated liver enzymes and low platelet count (HELLP) syndrome 8. Severe pre-eclampsia |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
De Run 4600
Veldhoven
5500 MB
Netherlands
5500 MB
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| info@studies-obsgyn.nl | |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Government
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | secondary analysis | 01/09/2014 | Yes | No | |
| Other publications | prediction model development | 01/05/2014 | 29/12/2020 | Yes | No |
| Results article | results | 01/10/2012 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.
