Condition category
Pregnancy and Childbirth
Date applied
31/01/2010
Date assigned
07/06/2010
Last edited
24/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jantien van der Heyden

ORCID ID

Contact details

De Run 4600
Veldhoven
5500 MB
Netherlands
-
j.vanderheyden@mmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

PPROMEXIL 2

Study hypothesis

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

Ethics committee of the University Hospital Maastricht

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient 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.

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant 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

Recruitment start date

01/01/2010

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

De Run 4600
Veldhoven
5500 MB
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5669111
info@studies-obsgyn.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

2014 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/24862166

Publication citations

Additional files

Editorial Notes