Trial of Early Screening Test for Pre-eclampsia and Growth Restriction (TEST)
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|ClinicalTrials.gov Identifier: NCT03674606|
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pre-Eclampsia Placenta Diseases Eclampsia Preeclampsia Fetal Growth Retardation Foetal Growth Restriction||Drug: Low dose aspirin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||546 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Three-armed parallel, multi-center, open-label randomised control trial|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Randomized-Controlled Trial of Early Screening Test for Pre-eclampsia and Growth Restriction|
|Actual Study Start Date :||February 1, 2014|
|Actual Primary Completion Date :||April 13, 2016|
|Actual Study Completion Date :||April 13, 2016|
Experimental: Routine low-dose aspirin
Subjects shall receive standard antenatal care as well as taking oral low-dose aspirin from the eligibility visit until 36-week gestation once daily, as prescribed by the research clinician. Fetal Medicine Foundation screening test results from the recruitment visit shall not be disclosed to the participants in this arm.
Drug: Low dose aspirin
One 75 mg aspirin dose taken daily
No Intervention: No aspirin
No low-dose aspirin will be prescribed. Fetal Medicine Foundation screening test results from the recruitment visit shall not be disclosed to the participants in this arm.
Active Comparator: Test-indicated low-dose aspirin
The Fetal Medicine Foundation screening test will be used to determine whether a subject is at high risk of developing any pre-eclampsia until 42-week gestation. Participants with risk > 1:8 must start low-dose aspirin treatment immediately. Participants with a risk < 1:8 will be excluded.
Drug: Low dose aspirin
One 75 mg aspirin dose taken daily
- The proportion of eligible women that agree to participate in the study [ Time Frame: Throughout study completion, less than 40 weeks ]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)
- Adherence to aspirin if prescribed [ Time Frame: 36 weeks ]Rate of adherence among study subjects prescribed aspirin.
- The proportion of study subjects in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination [ Time Frame: 36 weeks ]This outcome includes the subjectively recorded ease of acquisition (feasibility).
- The proportion of study subjects with a completed screening test who are issued the screening result within one week of having the test performed [ Time Frame: 1 week ]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).
- Attendance at study visits [ Time Frame: 36 weeks ]Rate of attendance of study visits by study subjects
- Satisfactory collection of all endpoints and variables [ Time Frame: 36 weeks ]Proportion of study subjects on which data for all other endpoints can be collected
- Any specific study protocol violations [ Time Frame: 36 weeks ]Proportion of study subjects for which protocol violations are recorded
- The rate of pre-eclampsia as defined by the International Society for the Study of Pre-eclampsia in Pregnancy. [ Time Frame: Childbirth ]
- The rate of fetal growth restriction. [ Time Frame: Childbirth ]
- Spontaneous or iatrogenic delivery. [ Time Frame: Prior to 34 and 37 completed weeks of gestation ]
- Rate of admission to the neonatal intensive care unit. [ Time Frame: Childbirth ]rate of placental abruption, any reported death (stillbirth, neonatal or infant death) and small for gestational age infants.
- Patient acceptability: ease of swallowing medication proportioned between categories of a 5-point Likert scale from "strongly agree" to "strongly disagree" [ Time Frame: 20--22 weeks ]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".
- Patient acceptability: reasons of failing compliance with study intervention regimen proportioned between answers to a 5-point multiple-choice question. [ Time Frame: 20--22 weeks ]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.
- Patient acceptability: opinions on the screening test proportioned between categories of a 3-point rating scale ranging from "Useful" to "Inconvenient" [ Time Frame: 20--22 weeks ]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"
- Patient acceptability: opinions for taking study intervention in the future proportioned between answers to a 3-point multiple-choice question. [ Time Frame: 20--22 weeks ]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"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674606
|National Maternity Hospital|