ow dose aspirin with an early screening test for pre-eclampsia and fetal growth restrictio

Not Applicable

Completed

• Conditions: Pregnancy/pre-eclampsia/fetal growth restriction; Pregnancy and Childbirth; Pre-eclampsia

• Registration Number: ISRCTN15191778
• Lead Sponsor: niversity College Dublin (Ireland)

Brief Summary

2016 protocol in https://www.ncbi.nlm.nih.gov/pubmed/27394381 (added 13/02/2020) 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30056389

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-10
• Study Completion: 2016-04-13
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 546

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> 2. Compliance with the study protocol. This will be measured at 20 week with a compliance questionnaire for those prescribed aspirin 75mg.<br> 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.<br> 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)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rate of pre-eclampsia. This is defined as those with BP 140/90 with +1 proteinuria at any time in pregnancy.<br> 2. Rate of fetal intrauterine growth restriction (IUGR), defined as birth-weight <10th centile for gestational age<br> 3. Spontaneous or iatrogenic delivery at <34 and < 37 completed weeks.<br> 4. Rate of admission to the neonatal intensive care unit<br> 5. Rate of placental abruption, any reported death (stillbirth, neonatal or infant death) and small for gestational age infants<br> 6. Patient acceptability will be assessed with a questionnaire at 34 weeks gestation<br>