Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000401954
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
18/04/2011
Date last updated
13/12/2021
Date data sharing statement initially provided
13/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does using progesterone reduce the miscarriage rate in high risk pregnancies?
Scientific title
In pregnant women with previous subfertility, does progesterone supplementation decrease the likelihood of miscarriage?
Secondary ID [1] 260000 0
Nil
Universal Trial Number (UTN)
U1111-1120-7674
Trial acronym
Pregnancy Maintenance Trial (PMTrial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Miscarriage 265656 0
Subfertility 265657 0
Recurrent miscarriage 265658 0
Condition category
Condition code
Reproductive Health and Childbirth 265789 265789 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 and 0 days, must be recruited prior to 7 weeks.
Intervention code [1] 264418 0
Treatment: Drugs
Intervention code [2] 264438 0
Prevention
Comparator / control treatment
Placebo pessary, carrier compound of the intervention pessary, identical in appearance.
Control group
Placebo

Outcomes
Primary outcome [1] 266540 0
Miscarriage
Timepoint [1] 266540 0
Completion of index pregnancy
Secondary outcome [1] 273997 0
Live birth
Timepoint [1] 273997 0
Completion of index pregnancy
Secondary outcome [2] 273998 0
Gestation at Birth
Timepoint [2] 273998 0
Completion of index pregnancy
Secondary outcome [3] 273999 0
Birth weight
Timepoint [3] 273999 0
Completion of index pregnancy
Secondary outcome [4] 274000 0
Threatened miscarriage, presentation to medical facility with bleeding and/or pain prior to 20 weeks gestation.
Timepoint [4] 274000 0
Completion of index pregnancy
Secondary outcome [5] 274001 0
Congenital anomaly
Timepoint [5] 274001 0
Completion of index pregnancy
Secondary outcome [6] 274002 0
Antepartum haemorrhage, presentation to medical facility with bleeding in pregnancy after 20 weeks gestation. Approximate volume will be recorded.
Timepoint [6] 274002 0
Completion of index pregnancy

Eligibility
Key inclusion criteria
1. Previously diagnosed with subfertility (no pregnancy after 12 months random unprotected intercourse, a history of 3 or more miscarriages, failing to achieve an ongoing pregnancy after 12 months of random unprotected intercourse)
2. Pregnancy less than 7 weeks + 0 days
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant as a result of Assisted Reproductive Technologies

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed, meet criteria, consented, enrolled, '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
Recruiting
Date of first participant enrolment
Anticipated
27/01/2012
Actual
20/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/02/2022
Actual
Sample size
Target
344
Accrual to date
197
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 264887 0
Hospital
Name [1] 264887 0
Mater Mothers' Hospital
Country [1] 264887 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] 264008 0
Hospital
Name [1] 264008 0
Mater Mothers' Hospital
Address [1] 264008 0
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 264008 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266867 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 266867 0
Mater Health Services
Stanley St
South Brisbane
Queensland 4101
Ethics committee country [1] 266867 0
Australia
Date submitted for ethics approval [1] 266867 0
14/04/2011
Approval date [1] 266867 0
12/01/2012
Ethics approval number [1] 266867 0
EC00332

Summary
Brief summary
This project will assess the effect of progesterone therapy on pregnancy outcomes in women previously diagnosed with subfertility.
It is hypothesised that progesterone supplementation in early pregnancy decreases the likelihood of miscarriage, and potentially late pregnancy complications in women with previous subfertility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32490 0
Dr Luke McLindon
Address 32490 0
Mater Mothers' Hospital Raymond Terrace South Brisbane Queensland 4101
Country 32490 0
Australia
Phone 32490 0
+61 7 3163 8111
Fax 32490 0
Email 32490 0
[email protected]
Contact person for public queries
Name 15737 0
Dr Chris Riley, RM
Address 15737 0
Fertility Assessment and Research Clinic
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 15737 0
Australia
Phone 15737 0
61 7 3163 8437
Fax 15737 0
61 7 3163 2137
Email 15737 0
[email protected]
Contact person for scientific queries
Name 6665 0
Dr Dr Luke McLindon
Address 6665 0
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 6665 0
Australia
Phone 6665 0
61 7 3163 8111
Fax 6665 0
Email 6665 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


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.