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Trial registered on ANZCTR


Registration number
ACTRN12612000150842
Ethics application status
Approved
Date submitted
2/02/2012
Date registered
3/02/2012
Date last updated
28/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Medical Management of Miscarriage Study
Scientific title
The Medical Management of Miscarriage Study: A randomized controlled clinical trial to determine the optimal dose of misoprostol for medical management of miscarriage before 13 weeks
Secondary ID [1] 279855 0
Nil
Universal Trial Number (UTN)
U1111-1127-8993
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failed early pregnancy or miscarriage 1984 0
Medical Management of Miscarriage 285741 0
Condition category
Condition code
Reproductive Health and Childbirth 2081 2081 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of 2 different doses of misoprostol (400 mcg and 800mcg[control]) administered intravaginally as part of the medical management of recognized miscarriage. The dose of misoprostol is administered at recruitment, and then the following day if the miscarriage is not considered complete. Comparison of efficacy to induce complete miscarriage, side-effect profile and patient tolerance and acceptance is to be determined. The duration of the study is anticipated to be 5 years.
Intervention code [1] 1005 0
Treatment: Drugs
Comparator / control treatment
The currently recommended dose of 800 mcg Misoprostol intravaginally administered at recruitment, and then the following day if the miscarriage is not considered complete.
Control group
Dose comparison

Outcomes
Primary outcome [1] 2901 0
Completion of miscarriage - clinical and ultrasound-based assessment
Timepoint [1] 2901 0
Day 7 - ultrasound criteria
Week 6 - clinical criteria
Secondary outcome [1] 4923 0
Number of visits to hospital /GP due to concern regarding bleeding and pain following administration of misoprostol, assessed using a patient-completed study questionnaire.
Timepoint [1] 4923 0
at 6 weeks
Secondary outcome [2] 4924 0
Experience of the side effects of the medication, assessed using a patient-completed study questionnaire. The side-effects evaluated include: fever/rigors, nausea, vomiting, diarrhoea, headache, tiredness, infections of the bladder or womb, distress.
Timepoint [2] 4924 0
at day 3
Secondary outcome [3] 4925 0
Comparison of haemoglobin leaves at enrolment and at follow-up on Day 7, assessed by blood test (full blood count).
Timepoint [3] 4925 0
at 7 days
Secondary outcome [4] 4926 0
Patient satisfaction with treatment, assessed using a patient-completed study questionnaire.
Timepoint [4] 4926 0
at 6 weeks

Eligibility
Key inclusion criteria
1Confirmed failed early pregnancy or incomplete miscarriage of up to 12 completed weeks of pregnancy
2Haemodynamically stable
3Ready access to emergency medical care (lives within 30 minutes of hospital)
4Willingness and consenting to undergo medical management
5Immediate availability of another responsible adult with a driver's license
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1Any suspicion of ectopic pregnancy
2Any features of infection
3Any features suggestive of gestational trophoblastic disease
4Allergy/Sensitivity to misoprostol or similar prostaglandins
5Women in whom prostaglandins would be contraindicated (severe reactive asthma and porphyria)
6Any woman with retained products of conception following a recent termination of pregnancy

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)
Enrolment - Eligible participants included women presenting with pregnancy loss between 6+0 and 12+6 weeks to the Emergency Department or Early Pregnancy Assessment Unit. Women with ultrasound confirmed incomplete or missed miscarriage (intra-uterine gestational sac with or without a fetal pole) are provided with written information regarding the surgical, expectant or medical management of miscarriage. Women electing medical management and meeting the inclusion criteria will then be offered participation in the study and provide written consent.
Randomization will be performed using a computer generated model with a block size of 6 stratified for study site. After enrolling the women into the study, allocation to the 400 mcg or 800 mcg group will be made by opening the next consecutively numbered, sealed opaque envelope. The allocated dose will be recorded in the medication chart and administered by the non-blinded attending clinicians or nursing staff; the study dose will not be revealed to the participating women who remain blinded throughout the study period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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)
Recruitment postcode(s) [1] 4938 0
4350

Funding & Sponsors
Funding source category [1] 284623 0
Charities/Societies/Foundations
Name [1] 284623 0
Toowoomba Hospital Foundation
Address [1] 284623 0
Toowoomba Base Hospital
Peechey St
Toowoomba
Qld 4350
Country [1] 284623 0
Australia
Primary sponsor type
Hospital
Name
Mater Mother's Hospital
Address
Raymond Tce
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 2010 0
Hospital
Name [1] 2010 0
Toowoomba Base Hospital
Address [1] 2010 0
Toowoomba Base Hospital
Peechey St
Toowoomba
Qld 4350
Country [1] 2010 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286616 0
Toowoomba Darling Downs Health Service District
Ethics committee address [1] 286616 0
Toowoomba Base Hospital
Peechey St
Toowoomba
Qld 4350
Ethics committee country [1] 286616 0
Australia
Date submitted for ethics approval [1] 286616 0
Approval date [1] 286616 0
01/08/2005
Ethics approval number [1] 286616 0
TDDHSD HREC 2005/018
Ethics committee name [2] 286617 0
Mater Health Services
Ethics committee address [2] 286617 0
Mater Health Services
Raymond Tce
South Brisbane
Qld 4101
Ethics committee country [2] 286617 0
Australia
Date submitted for ethics approval [2] 286617 0
Approval date [2] 286617 0
01/05/2007
Ethics approval number [2] 286617 0
MHS HREC 976M

Summary
Brief summary
The optimal dose of Misoprostol to be used in the medical management of miscarriage before 13 weeks has not been resolved. This study was undertaken to evaluate the effectiveness and side effect profile of two different dosages of Misoprostol.
Methods
A randomized controlled, equivalence study comparing 400mcg vs 800mcg Misoprostol per vaginum (PV) on an outpatient basis. The allocated dose was repeated the next day if clinically the products of conception had not been passed. Complete miscarriage was evaluated using two methods: ultrasound criteria on Day 7; and the need for surgical management (clinical criteria). Equivalence was demonstrated if the 95% confidence interval [CI] of the observed risk difference between the two doses for complete miscarriage lay between -15.0% and 15.0%. Differences in side effects and patient satisfaction were evaluated using patient-completed questionnaires.
Trial website
not applicable
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 36135 0
Address 36135 0
Country 36135 0
Phone 36135 0
Fax 36135 0
Email 36135 0
Contact person for public queries
Name 10194 0
Scott G Petersen
Address 10194 0
Mater Mother's Hospital
Raymond Tce
South Brisbane Qld 4101
Country 10194 0
Australia
Phone 10194 0
+61 7 31638111
Fax 10194 0
Email 10194 0
Scott.Petersen@mater.org.au
Contact person for scientific queries
Name 1122 0
Scott G Petersen
Address 1122 0
Mater Mother's Hospital
Raymond Tce
South Brisbane Qld 4101
Country 1122 0
Australia
Phone 1122 0
+61 7 31638111
Fax 1122 0
Email 1122 0
Scott.Petersen@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