Plain English Summary
Background and study aims
Pre-eclampsia is a condition that affects 2-8% of pregnancies. Previous studies have shown that aspirin can reduce the occurrence of pre-eclampsia in women with known risk factors but we know little for low risk populations. This study aims to assess if it is beneficial in terms of effectiveness and patient acceptability to routinely prescribe low dose aspirin to low risk women on the basis of a positive early pregnancy screening test for pre-eclampsia and fetal growth restriction. The specific aims of this study are:
1. Number of eligible women who agree to participate in the study.
2. Adherence to the study methodology
3. Number of women in whom it was possible to get first trimester abdominal uterine artery Doppler examination
4. Number of women with completed screening test who are issued the screening result on time
Who can participate?
Women who are expecting their first baby , less than 14 weeks pregnant at their first visit, not on aspirin, with enough English to understand the purpose of the study.
What does the study involve?
500 first time mothers with low-risk pregnancies will be randomly allocated to one of three groups from early pregnancy:
Group 1 will receive 75mg of aspirin until 36 weeks
Group 2 will not receive aspirin
Group 3 will receive 75mg of aspirin until 36 weeks only if they screen positive using the Fetal Medicine Foundation (FMF) early pregnancy screening test for pre-eclampsia and fetal growth restriction prediction. If this screening test is negative, group 3 will not receive aspirin.
All participants will undergo these first trimester screening tests but the results will only be given for group 3.
What are the possible benefits and risks of participating?
Benefits include detailed scans performed of the baby in the first and second trimester of pregnancy as well as monitoring of blood pressure. Mothers involved in the study will be contributing to a study which has the potential to significantly reduce the occurrence of pregnancy complications such as pre-eclampsia and fetal growth restriction which risks the lives of mothers and babies worldwide. Studies have shown that low dose aspirin appear to be safe for mother and baby, it is a medication frequently used by mothers who are at high risk of developing pre-eclampsia.
Where is the study run from?
The study will run from the National Maternity Hospital, Coombe Maternity Hospital and Rotunda Maternity Hospital, Dublin, Ireland.
When is the study starting and how long is it expected to run for?
The trial is starting in February 2014 and is expected to run for two years.
Who is funding the study?
Perinatal Ireland Consortium (Ireland)
Who is the main contact?
Professor Fionnuala McAuliffe PI
fionnuala.mcauliffe@ucd.ie
Trial website
Contact information
Type
Scientific
Primary contact
Prof Fionnuala McAuliffe
ORCID ID
Contact details
UCD Obstetrics & Gynaecolgy
School of Medicine and Medical Science
University College Dublin
National Maternity Hospital
Dublin
Dublin 2
Ireland
+353 637 3216
fionnuala.mcauliffe@ucd.ie
Additional identifiers
EudraCT number
2013-004241-17
ClinicalTrials.gov number
Protocol/serial number
TEST_PILOT_V1
Study information
Scientific title
An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and fetal growth restriction: A pilot study
Acronym
Study hypothesis
The hypothesis of this study is to assess if it is beneficial in terms of efficacy and patient acceptability to routinely prescribe low dose aspirin to nulliparous low risk women compared with test indicated aspirin on the basis of a positive early pregnancy screening test for pre-eclampsia and fetal growth restriction.
Ethics approval
National Maternity Hospital, Dublin, Ireland, 11/11/2013
Study design
Multi-centre randomized controlled open-labelled pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy / pre-eclampsia/ fetal growth restriction/ randomsied-controlled trial
Intervention
Following assessment for study eligibility at time of antenatal booking in the first trimester, women will undergo computer-generated randomisation to one of 3 antenatal management protocols:
1. Aspirin therapy 75mg daily commencing after a satisfactory1st trimester assessment, followed by a mid-trimester assessment and routine antenatal care thereafter (routine aspirin arm)
2. No aspirin therapy with 1st trimester assessment, mid-trimester assessment and routine antenatal care thereafter (control arm)
3. Postponement of decision regarding aspirin therapy until availability of the Fetal Medicine Foundation screening result for pre-eclampsia risk at time of 1st trimester assessment, with immediate commencement of aspirin 75mg daily in the screen positive subgroup, set at a false positive rate of 5% (screen & treat arm)
Assessment at the first trimester visit will include:
1. Assessment of blood pressure
2. Ultrasound scan: uterine artery doppler measurements
3. Blood tests: placental biomarkers to determine pre-eclampsia risk
The routine aspirin arm and those with a screen positive in the screen and treat arm will receive Aspirin 75mg from first trimester until 36 weeks of pregnancy and all participants will be asked to return for a visit at 20-22 weeks of pregnancy which will involve:
1. Blood pressure
2. Repeating the blood tests for placental biomarkers
3. Performing an ultrasound of fetal anatomy and uterine artery doppler assessment
Women will then attend for routine antenatal care until delivery
Intervention type
Drug
Phase
Not Applicable
Drug names
Aspirin
Primary outcome measure
1. Proportion of eligible women who agree to participate in the pilot study. This will be calculated by the % of women who agree to study participation out of all those eligible women who were approached for study participation after written consent has been obtained in the first trimester.
2. Compliance with the study protocol. This will be measured at 20 week with a compliance questionnaire for those prescribed aspirin 75mg.
3. Proportion of women in whom it was possible to obtain first trimester trans-abdominal uterine artery Doppler examination. This will be assessed at the first trimester visit.
4. Proportion of women with completed screening test who are issued the screening result on time. This will be assessed as the % of women who received a result of the screening test within one week of having the test performed in the screen and treat group (group 3)
Secondary outcome measures
1. Rate of pre-eclampsia. This is defined as those with BP 140/90 with +1 proteinuria at any time in pregnancy.
2. Rate of fetal intrauterine growth restriction (IUGR), defined as birth-weight <10th centile for gestational age
3. Spontaneous or iatrogenic delivery at <34 and < 37 completed weeks.
4. Rate of admission to the neonatal intensive care unit
5. Rate of placental abruption, any reported death (stillbirth, neonatal or infant death) and small for gestational age infants
6. Patient acceptability will be assessed with a questionnaire at 34 weeks gestation
Overall trial start date
01/02/2014
Overall trial end date
13/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women who are in their first pregnancy
2. Women who are able to speak and read English so that they can provide consent to be included in the study
3. Women who have a singleton pregnancy below 14 weeks
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
500 pregnant women
Participant exclusion criteria
1. Presence of fetal abnormality at the time of the first trimester scan
2. Women with known risk factors for pre-eclampsia or growth restricted babies who may already be on
Aspirin for this reason
3. Women already taking part in another study
4. Women who cannot take Aspirin
5. Women aged under 18 years
Recruitment start date
08/05/2014
Recruitment end date
01/02/2016
Locations
Countries of recruitment
Ireland
Trial participating centre
UCD Obstetrics & Gynaecolgy,
Dublin
Dublin 2
Ireland
Sponsor information
Organisation
University College Dublin (Ireland)
Sponsor details
c/o Dr Peter Doran
Clincial Research Centre
School of Medicine and Medical Science
Dublin
N/A
Ireland
+353 1 716 4582
peter.doran@ucd.ie
Sponsor type
University/education
Website
http://www.ucd.ie/medicine/ourresearch/researchcentres/ucdclinicalresearchcentre/
Funders
Funder type
Research organisation
Funder name
Perinatal Ireland (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list