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Trial registered on ANZCTR


Registration number
ACTRN12612001254886
Ethics application status
Approved
Date submitted
26/11/2012
Date registered
28/11/2012
Date last updated
23/08/2019
Date data sharing statement initially provided
23/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mifipristone and misoprostol compared to misoprostol alone in the treatment of first trimester miscarriage. A randomised control trial.
Scientific title
Among women with first trimester miscarriage, is the combination of mifepristone plus misoprostol superior to misoprostol alone for reducing the need for surgical uterine evacuation and repeat doses of misoprostol?
Secondary ID [1] 281589 0
nil
Secondary ID [2] 281596 0
nil
Universal Trial Number (UTN)
U1111-1137-3132
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First trimester miscarriage 287870 0
Condition category
Condition code
Reproductive Health and Childbirth 288236 288236 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mifepristone plus misoprostol. 200mg oral mifepristone. Participants take the misoprostol tablets home with them to take 2 days after the mifepristone at an oral dose of 400mcg followed by a further 400mcg 3 hrs later
Intervention code [1] 286115 0
Treatment: Drugs
Comparator / control treatment
Arm 1: Misoprostol alone. 600mcg oral misoprostol followed by a further 600mcg oral misoprostol 3 hrs later
Control group
Active

Outcomes
Primary outcome [1] 288425 0
Primary Outcome 1: Need for surgical uterine curettage as assessed by transvaginal ultrasound scan of retained products (mixed echogenicity within the uterine cavity of >15mm or intact gestational sac).
Timepoint [1] 288425 0
at 7-10 days post last dose of treatment
Primary outcome [2] 288426 0
Primary Outcome 2: Need for repeat dose of misoprostol (600mg PO followed by 600mcg PO 3hrs later) as assessed by transvaginal ultrasound scan of retained products of conception. Retained products defined as mixed echogenicity within the uterine cavity of >15mm or intact gestational sac.
Timepoint [2] 288426 0
at 7-10 days post last dose of treatment
Secondary outcome [1] 300128 0
Secondary Outcome 1: pelvic infection as determined by need for antibiotics as determined by follow up phone call at 2 weeks and review of clinical notes
Timepoint [1] 300128 0
within 31 days of trial entry for review of notes and phone call at 2 weeks post treatment
Secondary outcome [2] 300129 0
Secondary Outcome 2: duration of vaginal bleeding as determined by follow up phone call
Timepoint [2] 300129 0
2 weeks post treatment
Secondary outcome [3] 300130 0
Secondary Outcome 3: gastrointestinal symptoms such as nausea, vomiting and diarrhoea as determined by follow-up phone call
Timepoint [3] 300130 0
2 weeks post treatment

Eligibility
Key inclusion criteria
Patients will be included who have a positive serum beta hCG and are less than 13 weeks pregnant, as determined by the size of their gestational sac or crown rump length on ultrasound. Definitions for types of miscarriage are:
1) Early embryonic demise = Mean sac diameter (MSD) >20mm with nil internal structures
2) Anembryonic pregnancy = empty gestational sac of at least 12mm and no growth over 3 or more days
3) Early fetal demise = fetus crown rump length (CRL) at least 6mm with nil fetal heart beat on transvaginal USS
4) Incomplete miscarriage = mixed echogenicity within endometrial cavity +/- disordered gestational sac
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) severe haemorrhage or pain
2) pyrexia
3) allergy or contraindication to misoprostol or mifepristone
4) current anticoagulation

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)
Patients are referred to our Early Pregnancy Assessment Service (EPAS) by Local Medical Officers and Emergency Departments. If miscarriage is diagnosed at the initial visit the patients are counselled regarding the treatment options (medical vs surgical). If the patient elects medical management they will be seen by the clinic nurse who will discuss the trial, give out the patient information statement and gain consent. Eligible participants will be randomised to receive either misoprostol alone or mifepristone + misoprostol. Concealment will be achieved using sequentially numbered, opaque, sealed envelopes. Envelopes will be kept in the office of clinic nurse not involved in the study. We hope that by having clinic nurses rather than registrars and consultants consenting the participants we will avoid dependent relationships forming between participants and those involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/01/2013
Actual
26/02/2015
Date of last participant enrolment
Anticipated
Actual
12/04/2017
Date of last data collection
Anticipated
1/01/2018
Actual
12/04/2017
Sample size
Target
500
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14615 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 14616 0
The Maitland Hospital - Maitland
Recruitment postcode(s) [1] 27639 0
2305 - New Lambton
Recruitment postcode(s) [2] 27640 0
2320 - Maitland

Funding & Sponsors
Funding source category [1] 286386 0
Self funded/Unfunded
Name [1] 286386 0
Angela Dunford
Country [1] 286386 0
Australia
Primary sponsor type
Individual
Name
Nandini Somanathan
Address
Department of Obstetrics and Gynaecology
John Hunter Hospital
Lookout Road
New Lambton
NSW 2305
Country
Australia
Secondary sponsor category [1] 285177 0
Individual
Name [1] 285177 0
Monika Jha
Address [1] 285177 0
Department of Obstetrics and Gynaecology
John Hunter Hospital
Lookout Road
New Lambton
NSW 2305
Country [1] 285177 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288455 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 288455 0
Ethics committee country [1] 288455 0
Australia
Date submitted for ethics approval [1] 288455 0
21/11/2012
Approval date [1] 288455 0
21/11/2012
Ethics approval number [1] 288455 0
HNEHREC Reference No: 12/11/21/3.05
NSW HREC Reference No: HREC/12/HNE/407

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34984 0
Dr Angela Dunford
Address 34984 0
John Hunter Hospital Lookout Road
New Lambton NSW 2305
Country 34984 0
Australia
Phone 34984 0
+61 2 49214350
Fax 34984 0
Email 34984 0
[email protected]
Contact person for public queries
Name 18231 0
Angela Dunford
Address 18231 0
Department of Obstetrics and Gynaecology
John Hunter Hospital
Lookout Road
New Lambton
NSW 2305
Country 18231 0
Australia
Phone 18231 0
+61 249214350
Fax 18231 0
+61 249213133
Email 18231 0
[email protected]
Contact person for scientific queries
Name 9159 0
Angela Dunford
Address 9159 0
Department of Obstetrics and Gynaecology
John Hunter Hospital
Lookout Road
New Lambton
NSW 2305
Country 9159 0
Australia
Phone 9159 0
+61 249214350
Fax 9159 0
+61 249213133
Email 9159 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
Study has ceased. Data will be stored as per ethics requirements then sensitively destroyed.


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
No additional documents have been identified.