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Trial registered on ANZCTR
Registration number
ACTRN12619000328178
Ethics application status
Approved
Date submitted
25/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Screening for preeclampsia in pregnancy, a prospective, observational, cohort study.
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Scientific title
Screening for preeclampsia in pregnancy, a prospective, observational, cohort study.
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Secondary ID [1]
296497
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None
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Universal Trial Number (UTN)
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Trial acronym
NAPS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pregnancy
310280
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Preeclampsia
311726
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Condition category
Condition code
Reproductive Health and Childbirth
309014
309014
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0
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Antenatal care
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Reproductive Health and Childbirth
309015
309015
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is a prospective, observational, single-centre, cohort study, recruiting nulliparous women and their partners from Lyell McEwin Hospital (LMH), Adelaide, Australia. We will recruit a sample size of 1500 women (and their partners) who are experiencing a first-time pregnancy and receiving antenatal care at the LMH. Multiparous women will be excluded from this study.
The standard antenatal visit (9-13 weeks’ gestation) will proceed as usual with midwives collecting routine information from the women, along with current Down syndrome screening (ultrasound between 11-13 weeks’ gestation) and Fetal Medicine Foundation (FMF) preeclampsia screening. At this visit, midwives will discuss the Northern Adelaide Preeclampsia (NAPS) screening test to all nulliparous women and eligible women and their partners who give signed informed consent will be recruited.
Consent to participate includes i) obtaining delivery information (e.g. birthweight, length, head circumference, baby sex, and pregnancy complications) from maternal medical records; and ii) a cheek swab sample from the mother and the father of the baby. This is a simple test that involves twirling a swab/brush on the inner cheek for 15 seconds to obtain buccal (cheek) cells to obtain DNA and the time of the routine antenatal blood tests. The genetic information in the NAPS algorithms includes a range of maternal and paternal single nucleotide polymorphisms (SNPs). We are not testing for any genetic diseases or disabilities, so no other genetic information will be obtained.
Approximately 1-2 weeks following this first antenatal visit (and before 16 weeks’ gestation), all participants will be seen to discuss aneuploidy risk and preeclampsia risk. This visit is part of standard antenatal care, but the discussion about preeclampsia risk is a service provided to participants. Any women found to be at risk of developing preeclampsia on a positive screen of the FMF test, will be prescribed with preventative low dose aspirin (before 16 weeks) as this is routine standard practice for women at high risk early preeclampsia. Diagnosis of preeclampsia is new onset hypertension developing in second half of pregnancy with proteinuria or other multisystem complications (e.g. HELLP) (ISSHP criteria).
This study will be carried out for the duration of pregnancy and we will also collect information at delivery.
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Intervention code [1]
313758
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Early Detection / Screening
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Comparator / control treatment
Women without preeclampsia.
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Control group
Active
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Outcomes
Primary outcome [1]
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Preeclampsia. defined as systolic blood pressure >=140 mm Hg or diastolic blood pressure >=90 mm Hg, or both, on at least two occasions four hours apart after 20 weeks’ gestation
but before the onset of labour, or postpartum, with either proteinuria (24 hour urinary protein >=300 mg or spot urine protein:creatinine ratio >= 30 mg/mmol creatinine or urine dipstick protein =++) or any multisystem complication of preeclampsia (ISSHP criteria).
Currently there is no standard appropriate test to detect women at risk for preeclampsia, particularly in nulliparous women; around 1 in 10 women will develop preeclampsia. Based on the proposed study algorithm (NAPS), developed by Adelaide University researchers, in a validation cohort, approximately 1 in 5 women went on to develop preeclampsia. We are optimistic that the NAPS screening test will outperform the FMF test, and importantly predicts all preeclampsia, irrespective of gestational age at delivery.
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Assessment method [1]
319224
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Timepoint [1]
319224
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20 weeks’ or after, in gestation, but before the onset of labour.
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Secondary outcome [1]
367363
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Intrauterine growth restriction, defined as a birth weight <5th customised centile
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Assessment method [1]
367363
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Timepoint [1]
367363
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At delivery
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Secondary outcome [2]
367426
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Gestational diabetes mellitus, defined using the new World Health Organization classification (venous plasma blood glucose measurement at fasting of >=5.1 mmol/L or following an Oral Glucose Tolerance Test, a 2 hour level of >=8.5 mmol/L). Glucose was measured using an Enzymatic, hexokinase assay.
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Assessment method [2]
367426
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Timepoint [2]
367426
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24-28 weeks' gestation
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Secondary outcome [3]
367427
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Spontaneous preterm birth, obtained from the case notes, determined as spontaneous delivery before 37+0 weeks’ gestation.
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Assessment method [3]
367427
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Timepoint [3]
367427
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At delivery
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Secondary outcome [4]
367428
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Infant measurements (head circumference), measured using a flexible tape measure, in centimetres, and obtained from the case notes.
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Assessment method [4]
367428
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Timepoint [4]
367428
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At delivery
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Secondary outcome [5]
367430
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Small for gestational age, defined as a birth weight (measured using standard infant hospital scales and obtained from the case notes) <10th customized centile.
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Assessment method [5]
367430
0
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Timepoint [5]
367430
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At delivery
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Secondary outcome [6]
367615
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Infant measurements (length), measured using a flexible tape measure in centimetres, and obtained from the case notes.
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Assessment method [6]
367615
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Timepoint [6]
367615
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At delivery
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Secondary outcome [7]
367616
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Infant measurements (birth weight) using standard infant hospital scales and obtained from the case notes.
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Assessment method [7]
367616
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Timepoint [7]
367616
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At delivery
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Secondary outcome [8]
367622
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Large for gestational age, defined as a birth weight (measured using standard infant hospital scales and obtained from the case notes) >90th customized centile.
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Assessment method [8]
367622
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Timepoint [8]
367622
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At delivery
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Eligibility
Key inclusion criteria
All women experiencing a first-time pregnancy and receiving antenatal care at the Lyell McEwin Hospital will be included. Their partners will also be included, where available. Women of partners who are unavailable or decline to participate will still be included.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Multiparous women
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
All statistics for this study will be performed by a professional biostatistician with expertise in this area. Statistical analyses will be performed using R version 3.2.3.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/03/2019
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Actual
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Date of last participant enrolment
Anticipated
27/03/2020
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Actual
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Date of last data collection
Anticipated
2/10/2020
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
13253
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment postcode(s) [1]
25814
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5112 - Elizabeth Vale
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Funding & Sponsors
Funding source category [1]
301085
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Charities/Societies/Foundations
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Name [1]
301085
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Hospital Research Foundation Northern Adelaide Local Health Network Project Grant, Lyell McEwin Hospital
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Address [1]
301085
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Hospital Research Foundation
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, SA 5112
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Country [1]
301085
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Australia
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Primary sponsor type
Hospital
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Name
Lyell McEwin Hospital
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Address
Haydown Road
Elizabeth Vale, SA 5112
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Country
Australia
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Secondary sponsor category [1]
300694
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None
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Name [1]
300694
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Address [1]
300694
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Country [1]
300694
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301835
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Women's and Children's Health Network (WCHN) Human Research Ethics Committee
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Ethics committee address [1]
301835
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Level 2, Samuel Way Building
72 King William Road
North Adelaide 5006 SA
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Ethics committee country [1]
301835
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Australia
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Date submitted for ethics approval [1]
301835
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09/07/2018
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Approval date [1]
301835
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26/10/2018
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Ethics approval number [1]
301835
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HREC/18/WCHN/73
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Summary
Brief summary
Women who had preeclampsia are at greater risk for cardiovascular and related diseases and their infants are at risk of being born too small or dying. Although many aetiological risk factors have been identified for preeclampsia, at present it is not possible to effectively predict which women will develop pregnancy complications, particularly in first time pregnancies. This study aims to compare the UK developed fetal medicine foundation test with the locally developed Lyell McEwin Hospital preeclampsia screening test in all first-time pregnancies at the Lyell McEwin Hospital. Prevention of preeclampsia is an important goal of obstetrical care. The current study is needed to determine which test most effectively predicts onset of preeclampsia in nulliparous women so the introduction of this test can translate into routine antenatal care in Australia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Gus Dekker
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Address
88270
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Lyell McEwin Hospital, Women and Children's Division, Elizabeth Vale, 5112 SA
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Country
88270
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Australia
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Phone
88270
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+61 414909621
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Fax
88270
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Email
88270
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[email protected]
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Contact person for public queries
Name
88271
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Prof Gus Dekker
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Address
88271
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Lyell McEwin Hospital, Women and Children's Division, Elizabeth Vale, 5112 SA
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Country
88271
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Australia
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Phone
88271
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+61 414909621
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Fax
88271
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Email
88271
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[email protected]
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Contact person for scientific queries
Name
88272
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Prof Gus Dekker
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Address
88272
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Lyell McEwin Hospital, Women and Children's Division, Elizabeth Vale, 5112 SA
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Country
88272
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Australia
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Phone
88272
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+61 414909621
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Fax
88272
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Email
88272
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The data will only be shared by the study researchers who have projects approved by ethics committees to investigate pregnancy complications.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1453
Study protocol
376303-(Uploaded-25-02-2019-12-06-57)-Study-related document.docx
1454
Ethical approval
376303-(Uploaded-25-02-2019-12-07-37)-Study-related document.pdf
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.
Download to PDF