Pre-Eclampsia Clinical Trial
— TESTOfficial title:
An Open-label Randomized-Controlled Trial of Early Screening Test for Pre-eclampsia and Growth Restriction
Verified date | September 2018 |
Source | University College Dublin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study of aspirin use in pregnancy to prevent high blood pressure and growth restriction of the fetus
Status | Completed |
Enrollment | 546 |
Est. completion date | April 13, 2016 |
Est. primary completion date | April 13, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Nulliparous women. - Ability to speak and .read English - Singleton pregnancy at <14 weeks. - Willing to sign voluntarily a statement of informed consent to participate in the study. Exclusion Criteria: - Presence of fetal anomaly at the time of the first trimester scan - Women with known major risk factors for pre-eclampsia who should already be on Aspirin as per National Institute of Clinical Excellence (NICE) guidance; specifically chronic hypertension, underlying connective tissue, renal or vascular disorder, type 1 diabetes mellitus. - Under 18 years of age. - Currently enrolled in other clinical trials. - Contraindications to Aspirin therapy. |
Country | Name | City | State |
---|---|---|---|
Ireland | National Maternity Hospital | Dublin | |
Ireland | Rotunda Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin | National Maternity Hospital, Ireland, Perinatal Ireland, Royal College of Surgeons, Ireland |
Ireland,
Mone F, Mulcahy C, McParland P, Stanton A, Culliton M, Downey P, McCormack D, Tully E, Dicker P, Breathnach F, Malone FD, McAuliffe FM. An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and growth restriction (TEST): Trial protocol. Contemp Clin Trials. 2016 Jul;49:143-8. doi: 10.1016/j.cct.2016.07.003. Epub 2016 Jul 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of eligible women that agree to participate in the study | The proportion of eligible women that agree to participate in the study - this will be reflected as a proportion of the number of women approached at the screening stage (feasibility) | Throughout study completion, less than 40 weeks | |
Primary | Adherence to aspirin if prescribed | Rate of adherence among study subjects prescribed aspirin. | 36 weeks | |
Primary | The proportion of study subjects in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination | This outcome includes the subjectively recorded ease of acquisition (feasibility). | 36 weeks | |
Primary | The proportion of study subjects with a completed screening test who are issued the screening result within one week of having the test performed | This includes the number of women within the screen and treatment group that went beyond 16-weeks before receiving the screening test result as beyond this time LDA may not be effective (feasibility). | 1 week | |
Primary | Attendance at study visits | Rate of attendance of study visits by study subjects | 36 weeks | |
Primary | Satisfactory collection of all endpoints and variables | Proportion of study subjects on which data for all other endpoints can be collected | 36 weeks | |
Primary | Any specific study protocol violations | Proportion of study subjects for which protocol violations are recorded | 36 weeks | |
Secondary | The rate of pre-eclampsia as defined by the International Society for the Study of Pre-eclampsia in Pregnancy. | Childbirth | ||
Secondary | The rate of fetal growth restriction. | Childbirth | ||
Secondary | Spontaneous or iatrogenic delivery. | Prior to 34 and 37 completed weeks of gestation | ||
Secondary | Rate of admission to the neonatal intensive care unit. | rate of placental abruption, any reported death (stillbirth, neonatal or infant death) and small for gestational age infants. | Childbirth | |
Secondary | Patient acceptability: ease of swallowing medication proportioned between categories of a 5-point Likert scale from "strongly agree" to "strongly disagree" | Proportion of subjects who either 1) "strongly agree", 2) "agree", 3) neither agree/disagree", 4) disagree or 5) strongly disagree with the statement "Aspirin was easy to swallow". | 20--22 weeks | |
Secondary | Patient acceptability: reasons of failing compliance with study intervention regimen proportioned between answers to a 5-point multiple-choice question. | Proportion of subjects who chose either "Reservations of taking aspirin", "Bleeding", "It caused stomach upset", "I forgot" or "Other" as a reason for missing aspirin dose. | 20--22 weeks | |
Secondary | Patient acceptability: opinions on the screening test proportioned between categories of a 3-point rating scale ranging from "Useful" to "Inconvenient" | Proportion of subjects who chose either 1) "Useful", 2) "Neither useful/inconvenient" or 3) "Inconvenient" to complete the statement "With regards the screening test I found it" | 20--22 weeks | |
Secondary | Patient acceptability: opinions for taking study intervention in the future proportioned between answers to a 3-point multiple-choice question. | Proportion of subjects who chose either "Take aspirin routinely", "Take aspirin only if I was at risk" or "Neither" to complete the statement "In a future pregnancy I would" | 20--22 weeks |
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