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Trial registered on ANZCTR


Registration number
ACTRN12613000370707
Ethics application status
Approved
Date submitted
30/03/2013
Date registered
8/04/2013
Date last updated
19/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Artificial rupture of membranes versus repeat intra-vaginal prostaglandins for induction of labour: a randomised controlled trial

Scientific title
The effect of artificial rupture of membranes (ARM) following one dose of Prostaglandin vaginal gel (PGE2), versus ARM following repeat doses of PGE2, on time interval between induction and birth, maternal satisfaction, likelihood of obstetric intervention and adverse maternal/perinatal outcomes amongst women undergoing an induction of labour at term: a randomised controlled trial

Secondary ID [1] 282211 0
nil
Universal Trial Number (UTN)
U1111-1141-2364
Trial acronym
The ARRIVaL study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
induction of labour 288731 0
Condition category
Condition code
Reproductive Health and Childbirth 289087 289087 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women randomised to the ARM (artificial rupture of membranes) arm are to undergo ARM using an amnihook as soon as is practical from 6 hours following a single dose of vaginal 2mg (multiparas) or 1mg (nulliparas) PGE2, regardless of the Modified Bishop’s score.
Intervention code [1] 286827 0
Treatment: Drugs
Comparator / control treatment
Women randomised to the PGE2 arm with a Modified Bishop’s score <7 will receive a further 1mg dose of vaginal PGE2 (as soon as is practical from 6 hours following the initial dose); whilst those with a Modified Bishop’s score greater than or equal to 7 are to undergo an ARM.
Control group
Active

Outcomes
Primary outcome [1] 289197 0
Time from commencement of induction of labour until birth
Timepoint [1] 289197 0
Birth
Secondary outcome [1] 302011 0
Mode of birth
Timepoint [1] 302011 0
Birth
Secondary outcome [2] 302012 0
Proportion of births occurring during “business hours” (0800-1700)
Timepoint [2] 302012 0
Birth
Secondary outcome [3] 302013 0
Use of epidural in labour
Timepoint [3] 302013 0
Birth
Secondary outcome [4] 302014 0
Need for antibiotics in labour
Timepoint [4] 302014 0
Birth
Secondary outcome [5] 302015 0
Admission to Special Care or Intensive Care Nurseries
Timepoint [5] 302015 0
Birth
Secondary outcome [6] 302016 0
Post-partum haemorrhage (= estimated blood loss >1000ml)
Timepoint [6] 302016 0
Birth
Secondary outcome [7] 302017 0
Duration of admission
Timepoint [7] 302017 0
Hospital discharge

Eligibility
Key inclusion criteria
All women with live singleton pregnancies greater than or equal to 37+0 weeks planning induction of labour using intravaginal Dinoprostone (PGE2) will be suitable for inclusion in this study
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Fetus with major congenital abnormality
Multiple pregnancies
Intrauterine fetal death
Any contraindication to vaginal birth
Women <18 years
Inability to consent

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)
Information regarding the trial will be included as part of the welcome information for all women booking at the hospital. Potential participants will be identified by clinicians in the antenatal clinic at antenatal visits at greater than or equal to 37 weeks. All women booked for an induction of labour using intravaginal Prostaglandins at greater than or equal to 37 weeks will be provided with written information regarding the trial by clinicians and given the opportunity to discuss the details of the study with the research midwife. When the woman presents to the hospital to be induced, the treating clinician will ask the woman if she desires to be involved, she will be invited to sign a consent form, randomized and a staff information sheet will be filed in the medical record. The research midwife will keep a log of all potentially eligible participants and the reasons for participation or not as per CONSORT guidelines.

Sealed opaque envelopes will be prepared by MMRC and stored by the research midwife securely in the Birth Suite. The envelope will be opened by the midwife in Birth Suite at the time of her morning review (and after obtaining written consent). Given the nature of the proposed intervention (administration of PGE2/artificial rupture of membranes) it is not possible to blind the clinicians or the patient as to their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be according to computer-generated random allocation list into 2 study arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A sample size of 250 would detect
a) a difference of 5 hours (20.5 hours to 15.5 hours) in the time from 1st dose PGE2 to birth and
b) an increase in proportion of in-hours births from 25% to 44%
with a power of 80% and a type error of 0.05

These assumptions are based on the observed outcomes following the introduction of a policy change at Mater Health Services and Bundaberg Base Hospital.

Statistical analyses of the data will be performed by the investigators in consultation with a statistician. The initial analysis will assess the adequacy of randomization procedure in ensuring comparability of the study groups. In this analysis demographic and other baseline characteristics will be compared. Primary and secondary outcomes will be assessed comparing the study groups. The Chi squared test will be used for categorical outcomes and student’s t-test for data measured on a continuous scale. If imbalance is identified in important baseline characteristics or demographics, a second analysis will be undertaken controlling for these factors using multivariate analysis. The level of significance for the primary outcome measures is set at 0.05 and Bonferroni adjustment for multiple comparisons will be undertaken for secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 818 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 6636 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 286975 0
Other Collaborative groups
Name [1] 286975 0
Mater Medical Research Institute
Address [1] 286975 0
Raymond Tce
South Brisbane, QLD, 4101
Country [1] 286975 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Services
Address
Raymond Terrace
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 285764 0
None
Name [1] 285764 0
Address [1] 285764 0
Country [1] 285764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289023 0
Mater Health Services HREC
Ethics committee address [1] 289023 0
Raymond Tce
South Brisbane, QLD, 4101
Ethics committee country [1] 289023 0
Australia
Date submitted for ethics approval [1] 289023 0
01/03/2009
Approval date [1] 289023 0
01/07/2009
Ethics approval number [1] 289023 0
1315M

Summary
Brief summary
Induction of labour is very common and may be associated with increased obstetric intervention. Information which helps guide the best approach to induction would potentially benefit many women and may help reduce healthcare costs. It is proposed to conduct a randomised controlled trial of women undergoing induction of labour who have commenced induction with a single dose of intravaginal Prostaglandin gel (PGE2). Women would be randomised to PGE2 arm (continue to administer further doses of PGE2 until the cervix is ripened and then perform an artificial rupture of membranes (ARM) and commence Syntocinon infusion to induce contractions) or the ARM group (perform ARM immediately or as soon as technically possible, followed by Syntocinon infusion to induce contractions).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38842 0
Dr Michael Beckmann
Address 38842 0
Ground Floor, Aubigny Place
Mater Health Services
Raymond Tce
South Brisbane, QLD, 4101
Country 38842 0
Australia
Phone 38842 0
+617 3163 1594
Fax 38842 0
+617 3163 1949
Email 38842 0
michael.beckmann@mater.org.au
Contact person for public queries
Name 38843 0
Dr Michael Beckmann
Address 38843 0
Ground Floor, Aubigny Place
Mater Health Services
Raymond Tce
South Brisbane, QLD, 4101
Country 38843 0
Australia
Phone 38843 0
+617 3163 1594
Fax 38843 0
+617 3163 1949
Email 38843 0
michael.beckmann@mater.org.au
Contact person for scientific queries
Name 38844 0
Dr Michael Beckmann
Address 38844 0
Ground Floor, Aubigny Place
Mater Health Services
Raymond Tce
South Brisbane, QLD, 4101
Country 38844 0
Australia
Phone 38844 0
+617 3163 1594
Fax 38844 0
+617 3163 1949
Email 38844 0
michael.beckmann@mater.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary