Immediate delivery versus expectant care in women with ruptured membranes close to term

ISRCTN	ISRCTN44485060
DOI	https://doi.org/10.1186/ISRCTN44485060
Secondary identifying numbers	358378

Submission date: 17/03/2005
Registration date: 19/04/2005
Last edited: 18/12/2017

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

Prof Jonathan Morris
Scientific

L 2, Building 52
Department of Obstetrics and Gynaecology
Royal North Shore Hospital
St Leonards
NSW 2065
Australia

Phone	+61 (0)2 9926 7027
Email	jmorris@med.usyd.edu.au

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of immediate delivery versus expectant care in women with ruptured membranes close to term
Study acronym	PPROMT - Preterm Prelabour Rupture Of the Membranes close to Term
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	Preterm prelabour rupture of membranes
Intervention	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	Other
Primary outcome measure	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 study start date	01/01/2005
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1,812
Key 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
Key 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.
Date of first enrolment	01/01/2005
Date of final enrolment	31/12/2013

Locations

Countries of recruitment

Argentina
Australia
New Zealand
Norway
Poland
Romania
South Africa
United Kingdom

Study participating centre

L 2, Building 52

St Leonards
NSW 2065
Australia

Sponsor information

National Health and Medical Research Council (Australia)
Research council

Office of NHMRC (MDP 100)
GPO Box 9848
Canberra
2601
Australia

Website	http://www.nhmrc.gov.au/
"ROR"	https://ror.org/011kf5r70

Funders

Funder type

Research council

National Health and Medical Research Council (Australia) (ref: ID 358378)
Government organisation / National government

Alternative name(s): NHMRC
Location: Australia

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?
Protocol article	protocol	23/03/2006		Yes	No
Results article	results	30/01/2016		Yes	No

Editorial Notes

18/12/2017: publication reference added.
26/09/2007: the overall trial end date was extended. The previous end date of this trial was 31/05/2005.
12/02/2009: 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.
13/02/2009: Public title has been added.

As of 19/04/2011 the overall trial end date has been changed from 31/05/2011 to 31/12/2013.