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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.
Scientific title
Screening for preeclampsia in pregnancy, a prospective, observational, cohort study.
Secondary ID [1] 296497 0
None
Universal Trial Number (UTN)
Trial acronym
NAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 310280 0
Preeclampsia 311726 0
Condition category
Condition code
Reproductive Health and Childbirth 309014 309014 0 0
Antenatal care
Reproductive Health and Childbirth 309015 309015 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 313758 0
Early Detection / Screening
Comparator / control treatment
Women without preeclampsia.
Control group
Active

Outcomes
Primary outcome [1] 319224 0
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.
Timepoint [1] 319224 0
20 weeks’ or after, in gestation, but before the onset of labour.
Secondary outcome [1] 367363 0
Intrauterine growth restriction, defined as a birth weight <5th customised centile
Timepoint [1] 367363 0
At delivery
Secondary outcome [2] 367426 0
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.
Timepoint [2] 367426 0
24-28 weeks' gestation
Secondary outcome [3] 367427 0
Spontaneous preterm birth, obtained from the case notes, determined as spontaneous delivery before 37+0 weeks’ gestation.
Timepoint [3] 367427 0
At delivery
Secondary outcome [4] 367428 0
Infant measurements (head circumference), measured using a flexible tape measure, in centimetres, and obtained from the case notes.
Timepoint [4] 367428 0
At delivery
Secondary outcome [5] 367430 0
Small for gestational age, defined as a birth weight (measured using standard infant hospital scales and obtained from the case notes) <10th customized centile.
Timepoint [5] 367430 0
At delivery
Secondary outcome [6] 367615 0
Infant measurements (length), measured using a flexible tape measure in centimetres, and obtained from the case notes.
Timepoint [6] 367615 0
At delivery
Secondary outcome [7] 367616 0
Infant measurements (birth weight) using standard infant hospital scales and obtained from the case notes.
Timepoint [7] 367616 0
At delivery
Secondary outcome [8] 367622 0
Large for gestational age, defined as a birth weight (measured using standard infant hospital scales and obtained from the case notes) >90th customized centile.
Timepoint [8] 367622 0
At delivery

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiparous women

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2019
Actual
Date of last participant enrolment
Anticipated
27/03/2020
Actual
Date of last data collection
Anticipated
2/10/2020
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13253 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 25814 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 301085 0
Charities/Societies/Foundations
Name [1] 301085 0
Hospital Research Foundation Northern Adelaide Local Health Network Project Grant, Lyell McEwin Hospital
Country [1] 301085 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin Hospital
Address
Haydown Road
Elizabeth Vale, SA 5112
Country
Australia
Secondary sponsor category [1] 300694 0
None
Name [1] 300694 0
Address [1] 300694 0
Country [1] 300694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301835 0
Women's and Children's Health Network (WCHN) Human Research Ethics Committee
Ethics committee address [1] 301835 0
Ethics committee country [1] 301835 0
Australia
Date submitted for ethics approval [1] 301835 0
09/07/2018
Approval date [1] 301835 0
26/10/2018
Ethics approval number [1] 301835 0
HREC/18/WCHN/73

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

Contacts
Principal investigator
Name 88270 0
Prof Gus Dekker
Address 88270 0
Lyell McEwin Hospital, Women and Children's Division, Elizabeth Vale, 5112 SA
Country 88270 0
Australia
Phone 88270 0
+61 414909621
Fax 88270 0
Email 88270 0
gustaaf.dekker@adelaide.edu.au
Contact person for public queries
Name 88271 0
Gus Dekker
Address 88271 0
Lyell McEwin Hospital, Women and Children's Division, Elizabeth Vale, 5112 SA
Country 88271 0
Australia
Phone 88271 0
+61 414909621
Fax 88271 0
Email 88271 0
gustaaf.dekker@adelaide.edu.au
Contact person for scientific queries
Name 88272 0
Gus Dekker
Address 88272 0
Lyell McEwin Hospital, Women and Children's Division, Elizabeth Vale, 5112 SA
Country 88272 0
Australia
Phone 88272 0
+61 414909621
Fax 88272 0
Email 88272 0
gustaaf.dekker@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1453Study protocol    376303-(Uploaded-25-02-2019-12-06-57)-Study-related document.docx
1454Ethical 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.