Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Jonathan Morris


Contact details

L 2
Building 52
Department of Obstetrics and Gynaecology
Royal North Shore Hospital
St Leonards
NSW 2065
+61 (0)2 9926 7027

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of immediate delivery versus expectant care in women with ruptured membranes close to term


PPROMT - Preterm Prelabour Rupture Of the Membranes close to Term

Study hypothesis

That early planned delivery of women with PPROM close to term is associated with:
1. Less neonatal and maternal morbidity compared with expectant management
2. Fewer economic costs compared with expectant management

Ethics approval

Australia: Northern Sydney Central Coast Area Health Service, 01/06/2004
United Kingdom: Tayside Committee Medical Research Ethics A, 19/01/2006, ref: 05/S1401/187

All other centres will seek ethics approval before recruitment of the first participant.

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Preterm prelabour rupture of membranes


Immediate delivery (within 24 hours) versus expectant management.

Added as of 13/02/2009: The duration of follow-up is 4 months post estimated date of confinement (EDC) or the baby's due delivery date at term. The follow-up will be coordinated from the Australian coordinating centre at the Royal North Shore Hospital.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Neonatal sepsis

Secondary outcome measures

1. Secondary infant outcomes:
1.1. Respiratory distress
1.2. Perinatal mortality
1.3. Duration of stay in special care unit
1.4. Duration of stay in hospital
1.5. Birth weight
1.6. Apgar score at 5 minutes
1.7. Any assisted ventilation
1.8. Early infant development
2. Secondary maternal outcomes:
2.1. Chorioamnionitis
2.2. Endometritis treated with antibiotics
2.3. Post-partum fever
2.4. Placental abruption
2.5. Induction of labour
2.6. Failed induction of labour
2.7. Caesarean section
2.8. Assisted vaginal delivery
2.9. Maternal satisfaction
2.10. Views of care
2.11. Duration of hospitalisation
2.12. Antenatally and postnatally, time to fully establish breast feeding
2.13. Maternal emotional wellbeing
2.14. Anxiety and depression

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Current inclusion criteria as of 12/02/2009:
Singleton pregnancies, with confirmed ruptured membranes from 34 weeks to 36 weeks and 6 days gestation.

Previous inclusion criteria:
Pregnant women with preterm prelabour rupture of the membranes at 34 - 36 weeks

Participant type


Age group




Target number of participants


Participant exclusion criteria

Women who are in established labour, have clinical evidence of chorioamnionitis or other indications for immediate delivery such as meconium staining of the liquor or an antepartum haemorrhage or any other contraindication to expectant management will be excluded from the study. The presence of Group B streptococcus on urine or genital tract culture will not be a specific indication for exclusion from the study.

Recruitment start date


Recruitment end date



Countries of recruitment

Argentina, Australia, New Zealand, Norway, Poland, Romania, South Africa, United Kingdom

Trial participating centre

L 2, Building 52
St Leonards
NSW 2065

Sponsor information


National Health and Medical Research Council (Australia)

Sponsor details

Office of NHMRC (MDP 100)
GPO Box 9848

Sponsor type

Research council



Funder type

Research council

Funder name

National Health and Medical Research Council (Australia) (ref: ID 358378)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



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

2006 protocol in:
2015 results in:

Publication citations

  1. Protocol

    Morris JM, Roberts CL, Crowther CA, Buchanan SL, Henderson-Smart DJ, Salkeld G, Protocol for the immediate delivery versus expectant care of women with preterm prelabour rupture of the membranes close to term (PPROMT) Trial [ISRCTN44485060]., BMC Pregnancy Childbirth, 2006, 6, 9, doi: 10.1186/1471-2393-6-9.

  2. Results

    Morris JM, Roberts CL, Bowen JR, Patterson JA, Bond DM, Algert CS, Thornton JG, Crowther CA; PPROMT Collaboration, Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial, Lancet, 2015, doi: 10.1016/S0140-6736(15)00724-2.

Additional files

Editorial Notes

Please note that as of 26/09/2007 the overall trial end date was extended. The previous end date of this trial was 31/05/2005. Please note that this ISRCTN record has been extensively amended as of 12/02/2009. The changes include the following: 1. The following countries have been added to the countries of recruitment field: Argentina, New Zealand, Norway, Poland, Romania, South Africa, United Kingdom 2. The target number of participants was amended from 1,800 to 1,812 All other changes are recorded in the relevant fields. Public title has been added as of 13/02/2009. As of 19/04/2011 the overall trial end date has been changed from 31/05/2011 to 31/12/2013.