Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000093886
Ethics application status
Approved
Date submitted
17/01/2012
Date registered
18/01/2012
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prostaglandin gel versus oxytocin for induction of labour in term prelabour rupture of membranes
Scientific title
For women with term prelabour rupture of membranes who wish active management does use of PG gel result in better satisfaction and less need for oxytocin without increasing risk of neonatal sepsis.
Secondary ID [1] 279746 0
nil
Universal Trial Number (UTN)
Trial acronym
PO PROM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
term prelabour rupture of membranes 285604 0
Condition category
Condition code
Reproductive Health and Childbirth 285798 285798 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three doses of Prostaglandin F2 alpha gel 6 hours apart = first dose after obtaining consent

doses are 2mg each time for nulliparous women and 1mg initially and then 2 mg for multiparous women

gel will be inserted vaginally
Intervention code [1] 284058 0
Treatment: Drugs
Comparator / control treatment
Oxytocin infusion - standard regime used in B/sute for induction of labour - commencing as soon as consented and a bed available in b/suite.
Control group
Active

Outcomes
Primary outcome [1] 286307 0
onset of labour without need for further oxytocin
Timepoint [1] 286307 0
in labour
Secondary outcome [1] 295576 0
need fo augmentation with oxytocin - these will be assessed by review of charts after birth
Timepoint [1] 295576 0
in labour
Secondary outcome [2] 295577 0
rate of epidural
Timepoint [2] 295577 0
in labour
Secondary outcome [3] 295578 0
c/section rate
Timepoint [3] 295578 0
at birth
Secondary outcome [4] 295579 0
chorioamnionitis - assessed by review of charts - these are clincal diagnoses
Timepoint [4] 295579 0
during hospiotal stay or readmission within 6 weeks of delivery
Secondary outcome [5] 295580 0
neonatal sepsis - confirmed or suspected - as charted in the babys chart
Timepoint [5] 295580 0
whilst in hospital or needing readmission with such a diagnosis within 6 weeks of birth

Eligibility
Key inclusion criteria
gestational age >36 weeks and 6 days
Confirmed SROM
Singleton pregnancy
live fetus
cephalic presentation
informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
severe medical problem
compromised fetus
indication for immediate delivery
suspected sepsis
previous c/section
known gbs infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
all eligible women will be provided with written information on the study

after about an hour they will be approached to answer any questions

if willing to participate women will sign consent and an allocation will be performed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random table - equal blocks - allocation by research staff not involvd in clinical care - sequentaiily numbered sealed opaque enevelopes will contain the allocation

envelope will only be opened after signed consent
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2009
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
184
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284527 0
Self funded/Unfunded
Name [1] 284527 0
Country [1] 284527 0
Australia
Primary sponsor type
Hospital
Name
ipswich Hospital
Address
P O Box 73
Ipswich
Qld
4305
Country
Australia
Secondary sponsor category [1] 283456 0
Individual
Name [1] 283456 0
kassam Mahomed
Address [1] 283456 0
P O Box 73
Ipswich
Qld
4305
Country [1] 283456 0
Australia
Other collaborator category [1] 260454 0
Individual
Name [1] 260454 0
Chris Weekes
Address [1] 260454 0
Trainee registrar
Ipswich hospital
P O Box 73
Ipswich
Qld
4305
Country [1] 260454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286512 0
West Moreton South Burnett HSD HREC
Ethics committee address [1] 286512 0
WMDD HREC
School of Mental health
Dawson House
Sumner park
Richland Qld 4077
Ethics committee country [1] 286512 0
Australia
Date submitted for ethics approval [1] 286512 0
10/09/2008
Approval date [1] 286512 0
20/11/2008
Ethics approval number [1] 286512 0
5/09/2012

Summary
Brief summary
Term PROM is a common problem. Women have traditionally been offered oxytocin infusion. This requires intravenous fluids, continuous FHR monitoring and the woman is restricted to bed.
PG gel has been shown in a large RCT to be safe and effective but has not become widely used in the public sector.
This study will address safety and efficacy as well as womens satisfaction of the two methods of induction.
Trial website
nil
Trial related presentations / publications
nil yet
Public notes

Contacts
Principal investigator
Name 33644 0
A/Prof kassam mahomed
Address 33644 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 chelmsford ave
Ipswich
Qld
4305
Country 33644 0
Australia
Phone 33644 0
+61 407034283
Fax 33644 0
Email 33644 0
[email protected]
Contact person for public queries
Name 16891 0
A/Prof Kassam Mahomed
Address 16891 0
Senior Staff Specialist
Dept of Obstetrics
P O Box 73
Ipswich
Qld
4305
Country 16891 0
Australia
Phone 16891 0
+61 - 7 - 38101111
Fax 16891 0
Email 16891 0
[email protected]
Contact person for scientific queries
Name 7819 0
A/Prof Kassam Mahomed
Address 7819 0
Senior Staff Specialist
Dept of Obstetrics
P O Box 73
Ipswich
Qld
4305
Country 7819 0
Australia
Phone 7819 0
+61-7-38101111
Fax 7819 0
Email 7819 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProstaglandin gel versus oxytocin - prelabour rupture of membranes at term - A randomised controlled trial.2018https://dx.doi.org/10.1111/ajo.12788
N.B. These documents automatically identified may not have been verified by the study sponsor.