Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000254291
Ethics application status
Approved
Date submitted
27/11/2008
Date registered
13/05/2009
Date last updated
13/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting Adverse Pregnancy Outcomes (PAPO) Study: An observational study to determine factors in both male and female partners to predict healthy pregnancies and adverse pregnancy outcomes
Scientific title
Predicting Adverse Pregnancy Outcomes (PAPO) Study: An observational study to determine factors in both male and female partners to predict healthy pregnancies and adverse pregnancy outcomes
Universal Trial Number (UTN)
Trial acronym
PAPO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy Complications 4038 0
Condition category
Condition code
Reproductive Health and Childbirth 4241 4241 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Dietary, lifestlye, genetic and circulating (blood) factors will be observed once before pregnancy (if posible) and again at 12 weeks gesation in the mother. Fathers will have blood taken only at one time point. Pregnancy Outome data will be collected within 6 weeks of particpants giving birth.
Intervention code [1] 3758 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5127 0
Pregnancy outcome data will be collected from the volunteers medical records
Timepoint [1] 5127 0
At the end of delivery or pregnancy loss
Secondary outcome [1] 8630 0
Deoxyribonucleic acid (DNA) damage levels will be measured in lymphocytes using the cytokinesis block micronucleus (CBMN) assay.
Timepoint [1] 8630 0
One time point before pregnancy (the couple must be actively trying to get pregnant) and at 12 weeks gestation
Secondary outcome [2] 241546 0
Blood concentrations of folate, vitamin 12, homocysteine and enzyme polymorphisms within folate metabolism. These tests will be done by SA pathology using routine laborarty tests.
Timepoint [2] 241546 0
One time point before pregnancy (the couple must be actively trying to get pregnant) and at 12 weeks gestation

Eligibility
Key inclusion criteria
Recruit before 12 weeks gestation, Consent to participate
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Serious medical illness, lack of informed consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1318 0
5005
Recruitment postcode(s) [2] 1319 0
5112

Funding & Sponsors
Funding source category [1] 4217 0
Government body
Name [1] 4217 0
National Health and Medical Research Council (NHMRC)
Country [1] 4217 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
Level 5, 20 Allara Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 3791 0
None
Name [1] 3791 0
Address [1] 3791 0
Country [1] 3791 0
Other collaborator category [1] 498 0
Hospital
Name [1] 498 0
Women's and Children's Hospital
Address [1] 498 0
72 King William Road, Adelaide
South Australia, 5006
Country [1] 498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6272 0
Children, Youth and Women's Health Service (CYWHS) Human Research Ethics Committee
Ethics committee address [1] 6272 0
Ethics committee country [1] 6272 0
Australia
Date submitted for ethics approval [1] 6272 0
Approval date [1] 6272 0
28/05/2008
Ethics approval number [1] 6272 0
1481/6/09

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

Contacts
Principal investigator
Name 29173 0
Address 29173 0
Country 29173 0
Phone 29173 0
Fax 29173 0
Email 29173 0
Contact person for public queries
Name 12330 0
Dr Denise Furness
Address 12330 0
Research Centre for Reproductive Health, Discipline of Obstertrics and Gynaecology, Level 6 Medical School North, The Univertsity of Adelaide, Adelaide, South Australia, 5005
Country 12330 0
Australia
Phone 12330 0
+61 8 8303 4086
Fax 12330 0
Email 12330 0
[email protected]
Contact person for scientific queries
Name 3258 0
Dr Denise Furness
Address 3258 0
Research Centre for Reproductive Health, Discipline of Obstertrics and Gynaecology, Level 6 Medical School North, The Univertsity of Adelaide, Adelaide, South Australia, 5005
Country 3258 0
Australia
Phone 3258 0
+61 8 8303 4086
Fax 3258 0
Email 3258 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
SourceTitleYear of PublicationDOI
EmbaseThe association of parental methylenetetrahydrofolate reductase polymorphisms (MTHFR 677C > T and 1298A > C) and fetal loss: a case-control study in South Australia.2020https://dx.doi.org/10.1080/14767058.2018.1500546
N.B. These documents automatically identified may not have been verified by the study sponsor.