ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000522415

Ethics application status

Approved

Date submitted

19/04/2016

Date registered

21/04/2016

Date last updated

5/06/2019

Date data sharing statement initially provided

5/06/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Cervical Ripening Using Misoprostol vs Dinoprostone: A randomised, triple-blinded, interventional study comparing safety and efficacy in primiparous women

Scientific title

Cervical Ripening Using Misoprostol vs Dinoprostone: A randomised, triple-blinded, interventional study comparing safety and efficacy in primiparous women

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1182-0920

Trial acronym

CRUMD

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cervical Ripening

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

Misoprostol 200microgram slow release pessary is placed per vagina on admission to hospital. This occurs 48 hours prior to planned induction of labour. The cervix is reassessed 24 hours post administration and misoprostol pessary removed unless indicated earlier. (indications for early removal include active labour, ruptured membranes, abnormal fetal cardiotocography, uterine hyperstimulation)

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Dinoprostone 10mg slow release pessary is placed per vagina on admission to hospital. This occurs 2 days prior to planned induction of labour. The cervix is reassessed 24 hours post administration and dinoprostone pessary removed unless indicated earlier. (indications for early removal include active labour, ruptured membranes, abnormal fetal cardiotocography, uterine hyperstimulation)

Control group

Active

Outcomes

Primary outcome [1]

Number of women requiring further cervical ripening with cervical ripening balloon following treatment as assessed by Bishops' Score less than or equal to 7 following removal of treatment drug

Timepoint [1]

24 hours post insertion of treatment

Primary outcome [2]

Number of women requiring induction of labour with oxytocin as assessed by the number of women who have not achieved spontaneous labour following treatment

Timepoint [2]

48 hours post treatment

Primary outcome [3]

Number of women requiring intervention for uterine hyperstimulation that is assessed by the number of women having 6 or more contractions in 10 minutes who require tocolysis or other intervention for fetal cardiotocography changes

Timepoint [3]

within 24 hours of treatment

Secondary outcome [1]

Number of women requiring delivery by caesarean section as determined by review of medical record

Timepoint [1]

within 4 days of treatment

Secondary outcome [2]

Time gap from treatment to vaginal delivery as assessed by review of medical record

Timepoint [2]

within 4 days of treatment

Secondary outcome [3]

Neonatal morbidity or mortality as assessed by presence of hypoxic ischaemic encephalopathy, 5 minute apgar score <7, Neonatal Intensive Care admission

Timepoint [3]

within 24 hours of birth

Eligibility

Key inclusion criteria

1) Pregnant women between 37+0 and 41+4 weeks gestation
2) Having first baby
3) Induction of labour deemed medically indicated
4) Bishops score less than or equal to 4
5) age >=18
6) BMI <50 at booking visit

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

1) Active labour
2) Ruptured membranes
3) Non-cephalic presentation
4) Previous caesarean section or other uterine surgery
5) Unexplained vaginal bleeding >24 weeks gestation
6) Suspected or known chorioamnionitis
7) Suspected or known fetal compromise (abnormal antenatal fetal heart rate pattern, ultrasound showing fetal growth <10th centile, oligohydramnios, polyhydramnios, abnormal dopplers)
8) Unable to read or speak English without the aid of an interpreter

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)

Vaginal pessaries identical in appearance
Sealed unidentified packaging
Numbered packaging
Randomisation conducted by 3rd party external to study

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random allocation sequence

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

There will be 200 women per arm, 400 total population

Misoprostol has been compared to dinoprostone in a phase III trial called the EXPIDITE study.

Based on the number of primiparous births we have at John Hunter Hospital, to replicate Wing et al with a 26% reduction in the use of oxytocin with a power of 90% and a p value <0.05 we would need 72 women per arm

In order to reduce the rate of CRB use at John Hunter Hospital from 28% to 14% with a power of 90% and p value <0.05 we would need 173 women per arm.

To replicate the difference in tachysystole rates of 13% and 4% with a 90% power and a p value <0.05 we will need 200 women per arm

5 of the 6 endpoints of this trial are dichotomous variables and so the chi-square test will be used to test for differences between groups
Time to vaginal delivery will be tested using Cox Proportional Hazards Regression

Wing D, Brown R, Plante L, Miller H, Rugarn O, Powers B; Misoprostol Vaginal Insert and Time to Vaginal Delivery (Obstet Gynecol 2013;122:201–9)

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

Misoprostol vaginal insert withdrawn from market world wide by Ferring Pharmaceuticals. TGA approval withdrawn 30.04.2019

Date of first participant enrolment

Anticipated

Actual

13/10/2015

Date of last participant enrolment

Anticipated

20/12/2019

Actual

14/04/2019

Date of last data collection

Anticipated

28/06/2019

Actual

Sample size

Target

400

Accrual to date

Final

208

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton Heights

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

John Hunter Hospital

Address [1]

Lookout Rd
New Lambton Heights
NSW 2305

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Ferring Pharmaceuticals PTY Ltd

Address [2]

20 Bridge Street,
Pymble NSW,2073

Country [2]

Australia

Primary sponsor type

Hospital

Name

John Hunter Hospital

Address

Lookout Rd
New Lambton Heights
NSW 2305

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 1
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/04/2015

Approval date [1]

02/06/2015

Ethics approval number [1]

15/05/20/3.03

Summary

Brief summary

Misoprostol and Dinoprostone are both medications used to ripen a woman's cervix in preparation for labour.
In a phase III trial by Wing et al misoprostol vaginal insert, when compared to dinoprostone vaginal insert, was thought to reduce the time from insert to vaginal delivery and decrease the number of women needing further intervention by oxytocin for induction of labour by 26% without an increase in the complications of caesarean section or neonatal morbidity. Misoprostol was found to increase the rate of tachysystole (too frequent uterine contractions) to 13% compared with 4% for dinoprostone. Wing et al used both primiparous women and multiparous women in their study. 
We hypothesize that by using misoprostol in primiparous women only we may still be able to achieve the significant reduction in need for other interventions for induction of labour but without the significant increase in rates of uterine tachysystole. 

Women admitted to the study will have either the misoprostol or dinoprostone inserted for cervical ripening and data collected on whether or not they then needed to have a cervical ripening balloon for further ripening, whether they needed oxytocin for induction of labour, whether they had too many contractions that required intervention to control, what their mode of delivery was, what the time interval between when the pessary was inserted and when they delivered and whether or not there were any neonatal complications.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Angela Boulton

Address

John Hunter Hospital
Lookout Rd
New Lambton Heights
NSW 2305

Country

Australia

Phone

+61 2 4921 4385

Fax

Angela.Boulton@hnehealth.nsw.gov.au

Contact person for public queries

Name

Angela Boulton

Address

John Hunter Hospital
Lookout Rd
New Lambton Heights
NSW 2305

Country

Australia

Phone

+61 2 4921 4385

Fax

Angela.Boulton@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Gracia Chong

Address

John Hunter Hospital
Lookout Rd
New Lambton Heights
NSW 2305

Country

Australia

Phone

+61 2 4921 4385

Fax

Gracia.Chong@hnehealth.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

de-identified individual participant data underlying published trial results

When will data be available (start and end dates)?

immediately following publication to no end date determined

Available to whom?

Ferring pharmaceuticals as per funding agreement. It will also be made available to researchers on a case-by-case basis who provide a methodologically sound proposal

Available for what types of analyses?

meta-analyses

How or where can data be obtained?

access subject to approvals by principal investigator

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2199	Clinical study report				This will be available when completed

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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