Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000405910
Ethics application status
Approved
Date submitted
14/04/2011
Date registered
19/04/2011
Date last updated
13/12/2021
Date data sharing statement initially provided
13/12/2021
Date results information initially provided
13/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does using progesterone in threatened miscarriage increase the live birth rate?
Scientific title
In women with threatened miscarriage, does progesterone supplementation increase the likelihood of live birth?
Secondary ID [1] 260001 0
Nil
Universal Trial Number (UTN)
U1111-1120-7707
Trial acronym
Supporting Threatened Outcomes with Progesterone
(STOP trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Threatened Miscarriage 265659 0
Condition category
Condition code
Reproductive Health and Childbirth 265790 265790 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progesterone pessary 400 mg nightly, until 12 weeks + 0 days
Intervention code [1] 264419 0
Treatment: Drugs
Intervention code [2] 264451 0
Prevention
Comparator / control treatment
Placebo pessary, identical in appearance, containing carrier compound of intervention pessary, until 12 weeks + 0 days
Control group
Placebo

Outcomes
Primary outcome [1] 266541 0
Live Birth
Timepoint [1] 266541 0
Completion of index pregnancy
Secondary outcome [1] 276004 0
Complete miscarriage
Timepoint [1] 276004 0
Completion of index pregnacy
Secondary outcome [2] 276005 0
Gestation at birth
Timepoint [2] 276005 0
Completion of index pregnancy
Secondary outcome [3] 276006 0
Birth weight
Timepoint [3] 276006 0
Completion of index pregnancy
Secondary outcome [4] 276007 0
Congenital anomaly
Timepoint [4] 276007 0
Completion of index pregnancy
Secondary outcome [5] 276008 0
Antepartum haemorrhage
Timepoint [5] 276008 0
Completion of index pregnancy

Eligibility
Key inclusion criteria
Threatened miscarriage
Live intra-uterine pregnancy
Gestation less than 10 weeks + 0 days
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy as a result of Assisted Reproductive Technologies

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)
Informed, meet criteria, consented, enroled, 'script' given, dispensed as blinded therapy at pharmacy according to randomisation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated variable block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2012
Actual
8/02/2012
Date of last participant enrolment
Anticipated
Actual
29/03/2019
Date of last data collection
Anticipated
Actual
29/03/2019
Sample size
Target
386
Accrual to date
Final
279
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 264888 0
Hospital
Name [1] 264888 0
Mater Mothers' Hospital
Country [1] 264888 0
Australia
Primary sponsor type
Individual
Name
Dr Luke McLindon
Address
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 264021 0
Hospital
Name [1] 264021 0
Mater Mothers' Hospital
Address [1] 264021 0
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 264021 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266844 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 266844 0
Mater Health Services
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country [1] 266844 0
Australia
Date submitted for ethics approval [1] 266844 0
14/04/2011
Approval date [1] 266844 0
16/01/2012
Ethics approval number [1] 266844 0
EC00332

Summary
Brief summary
This project will assess the effect of progesterone therapy on pregnancy outcomes in women presenting with threatened miscarriage. It is hypothesised that progesterone supplementation for early threatened pregnancy increases the live birth rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32491 0
Dr Luke McLindon
Address 32491 0
Mater Mothers' Hospital Raymond Terrace South Brisbane Queensland 4101
Country 32491 0
Australia
Phone 32491 0
+61731638111
Fax 32491 0
Email 32491 0
lucas.mclindon@mater.org.au
Contact person for public queries
Name 15738 0
Miss Chris Riley, RM
Address 15738 0
Fertility Assessment and Research Clinic
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 15738 0
Australia
Phone 15738 0
61 7 3163 8437
Fax 15738 0
61 7 3163 2137
Email 15738 0
naturalfertility@mater.org.au
Contact person for scientific queries
Name 6666 0
Dr Dr Luke McLindon
Address 6666 0
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 6666 0
Australia
Phone 6666 0
61 7 3163 8111
Fax 6666 0
Email 6666 0
lucas.mclindon@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 336813-(Uploaded-30-11-2021-17-12-40)-Basic results summary.docx
Plain language summaryNo In women with threatened miscarriage as apparent f... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProgestogen for treating threatened miscarriage.2018https://dx.doi.org/10.1002/14651858.CD005943.pub5
EmbaseProgestogens for preventing miscarriage: a network meta-analysis.2021https://dx.doi.org/10.1002/14651858.CD013792.pub2
EmbaseProgesterone for women with threatened miscarriage (STOP trial): a placebo-controlled randomized clinical trial.2023https://dx.doi.org/10.1093/humrep/dead029
N.B. These documents automatically identified may not have been verified by the study sponsor.