Low dose aspirin with an early screening test for pre-eclampsia and fetal growth restriction

• Register: ISRCTN
• Last refreshed on: 3 March 2020
• Main ID: ISRCTN15191778
• Date of registration: 10/02/2014
• Prospective Registration: Yes
• Primary sponsor: University College Dublin (Ireland)
• Public title: Low dose aspirin with an early screening test for pre-eclampsia and fetal growth restriction
• 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
• Date of first enrolment: 08/05/2014
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15191778
• Study type: Interventional
• Study design: Multicentre randomized controlled open-labelled pilot trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Fionnuala McAuliffe

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy/pre-eclampsia/fetal growth restriction
Pregnancy and Childbirth
Pre-eclampsia

Intervention(s)

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

Primary Outcome(s)

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(s)

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

Secondary ID(s)

2013-004241-17

NCT03674606

TEST_PILOT_V1

Source(s) of Monetary Support

Perinatal Ireland (Ireland)

Ethics review

Status:
Approval date:
Contact:

National Maternity Hospital, Dublin, Ireland, 11/11/2013

Results

• Results available: Yes
• Date Completed: 13/04/2016