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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Time from commencement of induction of labour until birth

Timepoint [1]

Birth

Secondary outcome [1]

Mode of birth

Timepoint [1]

Birth

Secondary outcome [2]

Proportion of births occurring during “business hours” (0800-1700)

Timepoint [2]

Birth

Secondary outcome [3]

Use of epidural in labour

Timepoint [3]

Birth

Secondary outcome [4]

Need for antibiotics in labour

Timepoint [4]

Birth

Secondary outcome [5]

Admission to Special Care or Intensive Care Nurseries

Timepoint [5]

Birth

Secondary outcome [6]

Post-partum haemorrhage (= estimated blood loss >1000ml)

Timepoint [6]

Birth

Secondary outcome [7]

Duration of admission

Timepoint [7]

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

Sex

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

1/10/2010

Actual

1/10/2010

Date of last participant enrolment

Anticipated

30/05/2013

Actual

1/09/2014

Date of last data collection

Anticipated

Actual

1/12/2014

Sample size

Target

250

Accrual to date

Final

250

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Mother's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Mater Medical Research Institute

Address [1]

Raymond Tce
South Brisbane, QLD, 4101

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mater Health Services

Address

Raymond Terrace
South Brisbane, QLD, 4101

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Health Services HREC

Ethics committee address [1]

Raymond Tce
South Brisbane, QLD, 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2009

Approval date [1]

01/07/2009

Ethics approval number [1]

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

Dr Michael Beckmann

Address

Ground Floor, Aubigny Place
Mater Health Services
Raymond Tce
South Brisbane, QLD, 4101

Country

Australia

Phone

+617 3163 1594

Fax

+617 3163 1949

michael.beckmann@mater.org.au

Contact person for public queries

Name

Michael Beckmann

Address

Ground Floor, Aubigny Place
Mater Health Services
Raymond Tce
South Brisbane, QLD, 4101

Country

Australia

Phone

+617 3163 1594

Fax

+617 3163 1949

michael.beckmann@mater.org.au

Contact person for scientific queries

Name

Michael Beckmann

Address

Ground Floor, Aubigny Place
Mater Health Services
Raymond Tce
South Brisbane, QLD, 4101

Country

Australia

Phone

+617 3163 1594

Fax

+617 3163 1949

michael.beckmann@mater.org.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Prostaglandin vaginal gel induction of labor comparing amniotomy with repeat prostaglandin gel.	2015	https://dx.doi.org/10.1016/j.ajog.2015.07.043
Embase	Induction of labor using prostaglandin vaginal gel: Cost analysis comparing early amniotomy with repeat prostaglandin gel.	2016	https://dx.doi.org/10.1016/j.ejogrb.2016.01.041
Embase	Measuring women's experience of induction of labor using prostaglandin vaginal gel.	2017	https://dx.doi.org/10.1016/j.ejogrb.2016.12.032
Embase	Predictors of mode of birth and duration of labour following induction using prostaglandin vaginal gel.	2017	https://dx.doi.org/10.1111/ajo.12588

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically