Condition category
Pregnancy and Childbirth
Date applied
15/10/2012
Date assigned
16/10/2012
Last edited
16/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study of 3000 pregnant women with pre-eclampsia (high blood pressure, fluid retention and protein in the urine (proteinuria) in pregnancy) by collecting urine and comparing different diagnostic tests to find the most appropriate and effective method that predicts pre-eclampsia and its severity is needed to provide these women with the best possible care. Our aim is to find the most efficient assessment tool for diagnosing pre-eclampsia.

Who can participate?
Pregnant women, aged between 18 and 45 years of age from participating hospital trusts across England.

What does the study involved?
Participants will be invited to give a small urine sample when screened for pre-eclampsia, following 24 hour urine collection and at delivery. Woman will be asked to allow the researcher access to clinical data about them and their baby. At the end of the study the urine samples will be analysed in a laboratory using the current standard techniques for identifying pre-eclampsia.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, but the findings from the study should benefit to future women who have suspected pre-eclampsia. This study may also help the NHS to develop more cost effective diagnosis techniques. There are no known risks to the patients taking part.

Where is the study run from?
Newcastle Upon Tyne Hospitals NHS Trust in collaboration with Newcastle University.

When is the study starting and how long is it expected to run for?
Recruitment will start beginning of November 2012 and participants will be enrolled on the study for a period of their pregnancy.

Who is funding the study?
NIHR Health Technology Programme and Newcastle University (UK)

Who is the main contact?
Dr Jason Waugh
Jason.waugh@nuth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jason Waugh

ORCID ID

Contact details

Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
-
jason.waugh@nuth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6213; HTA 10/65/02

Study information

Scientific title

Spot protein creatinine ratio (SPCr) and spot albumin creatinine ratio (SACr) in the assessment of pre-eclampsia: a diagnostic accuracy study with decision analytic model based economic evaluation and acceptability analysis

Acronym

DAPPA

Study hypothesis

Investigations aimed at determining which method of measurement and which diagnostic thresholds are the most accurate in predicting not just preeclampsia but the clinical significant outcomes which will help inform clinicians on the correct clinical management of gestational hypertensive disorders during pregnancy. This in turn will improve the clinicians ability predict maternal and fetal outcomes.

More details can be found here: http://www.nets.nihr.ac.uk/projects/hta/106502
Further details can be found here: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0011/81677/PRO-10-65-02.pdf

Ethics approval

NRES Committee North East - County Durham & Tees Valley, 21/09/2012, ref: 12/NE/0301

Study design

Multi-centre prospective cohort observation sample collection study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

The patient information sheet is available by contacting the Chief Investigator, Jason Waugh (jason.waugh@nuth.nhs.uk)

Condition

Pre-eclampsia

Intervention

This study involves 3000 women who will provide urine samples during admission to hospital with suspected preeclampsia across England. Women will be in the study for the duration of pregnancy providing three urine samples.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Diagnostic accuracy of point of care and laboratory assessments of Spot Protein Creatine Ratio (SPCr) and Spot Albumin Creatine Ratio (SACr) compared with 24 hour urine protein measurement at different thresholds in diagnosing and predicting severe Pre-Eclampsia (PE)

Secondary outcome measures

1. To assess the accuracy of point of care assessments of SPCr and SACr at different thresholds in diagnosing PE compared to 24 hour urine protein measurement
2. To identify the most accurate laboratory assay method of 24 hour proteinuria in assessment of PE
3. To estimate the accuracy of both quantitative and point of care assessments of SPCr and SACr at different thresholds in predicting adverse fetal outcomes
4. To develop a decision analytic model to estimate the diagnostic utility potential of replacing the 24 hour protein with the SPCr or SACr
5. To assess the cost effectiveness of SPCr or SACr in comparison to the 24 hour urine protein measurement

Overall trial start date

01/11/2012

Overall trial end date

01/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women aged between 16- 45 years
2. More than 20 weeks gestation with confirmed gestational hypertension (systolic BP >140 mmHg and diastolic BP >90 mmHg)
3. Trace or more proteinuria on automated dipstick urinalysis. This is below the threshold of 1+ considered "test positive" by NICE and will thus allow exploration of the lower threshold for the index tests, i.e. below 300 mg/l protein
4. Ability of give informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3000

Participant exclusion criteria

1. Women with gestational hypertension but no proteinuria on automated dipstick urinalysis
2. Proteinuria before 20 weeks gestation
3. Pre-existing renal disease, pre-gestational diabetes and chronic hypertension
4. Those who are unable to provide informed consent
5. Those women who are already participating in a clinical trial of an investigational medicinal product (CTIMP)

Recruitment start date

01/11/2012

Recruitment end date

01/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle Hospitals NHS Foundation Trust (UK)

Sponsor details

Royal Victoria Infirmary
Joint Research Office
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/06/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/11/2016: No publications found, verifying study status with principal investigator.