Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001051932
Ethics application status
Approved
Date submitted
6/10/2011
Date registered
7/10/2011
Date last updated
7/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mifepristone for early termination of pregnancy.
Scientific title
Termination of early pregnancy using mifepristone 200mg followed by buccal administration of misoprostol 800mcg – retrospective review of efficacy and safety – Australian Authorised Prescriber Program.
Secondary ID [1] 273174 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Termination of first trimester pregnancy. 278926 0
Condition category
Condition code
Reproductive Health and Childbirth 279106 279106 0 0
Abortion

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Mifepristone 200mg tablet followed 36-48 hours later by misoprostol 800mcg tablets by buccal administration. Observation for adverse events for up to 21 days post treatment.
Intervention code [1] 269505 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279746 0
Rate of procedure failure as measured by pregnancy test and ultrasound.
Timepoint [1] 279746 0
14 to 21 days post treatment
Secondary outcome [1] 294358 0
incidence of adverse events - reported to clinic following treatment. Serious adverse events associated with the procedure include hemorrhage, retained products of conception and very rarely, infection.
Timepoint [1] 294358 0
Adverse events are monitored from day of treatment to follow up which is most often up to 14 to 21 days post treatment.
Secondary outcome [2] 294359 0
patient preferences at follow up - completion of a patient questionnaire regarding patients experience of pain, bleeding and overall satisfaction with the procedure.
Timepoint [2] 294359 0
A follow up appointment occurs in the time period of 14 to 21 days post dosing and at that visit a patient questionnaire is completed.

Eligibility
Key inclusion criteria
Confirmed pregnancy up to 9 weeks gestation.
Informed consent.
No contraindications.
Must meet legal requirements for termination of pregnancy in the state where the service is provided.
Minimum age
14 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
More than 9 weeks since the last menstrual period (confirmed by ultrasound).
Known or suspected ectopic pregnancy.
Concomitant administration of anticoagulants or corticosteroids.
Adrenal failure, inherited porphyria or a haemorrhagic disorder.
Allergy to mifepristone or misoprostol.
Intrauterine device insitu
Pelvic infection

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
13000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269996 0
Charities/Societies/Foundations
Name [1] 269996 0
Marie Stopes International Australia
Country [1] 269996 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Marie Stopes International Australia
Address
GPO Box 1635, Melbourne, Victoria, Australia 3001
Country
Australia
Secondary sponsor category [1] 268979 0
None
Name [1] 268979 0
Address [1] 268979 0
Country [1] 268979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271957 0
Queensland Clinical Trials Network
Ethics committee address [1] 271957 0
PO Box 2366, Toowong DC, 4066, Qld, Australia
Ethics committee country [1] 271957 0
Australia
Date submitted for ethics approval [1] 271957 0
Approval date [1] 271957 0
30/05/2009
Ethics approval number [1] 271957 0
EC00427

Summary
Brief summary
A retrospective review of the safety and efficacy of the use of mifepristone 200mg with misoprostol 800mcg buccally for termination of pregnancy less than 9 weeks gestation. Summary of the findings from an Authorised Prescriber program in Australia.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 33245 0
Address 33245 0
Country 33245 0
Phone 33245 0
Fax 33245 0
Email 33245 0
Contact person for public queries
Name 16492 0
Business Development Director
Address 16492 0
Marie Stopes International Australia
PO Box 1635
Melbourne 3001
Victoria
Australia
Country 16492 0
Australia
Phone 16492 0
+613 9658 7533
Fax 16492 0
Email 16492 0
[email protected]
Contact person for scientific queries
Name 7420 0
Business Development Director
Address 7420 0
Marie Stopes International Australia
PO Box 1635
Melbourne 3001
Victoria, Australia
Country 7420 0
Australia
Phone 7420 0
+613 9658 7533
Fax 7420 0
Email 7420 0
[email protected]

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
No additional documents have been identified.