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Trial record 42 of 251 for:    ASPIRIN AND low-dose aspirin

Trial of Early Screening Test for Pre-eclampsia and Growth Restriction (TEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03674606
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Perinatal Ireland
National Maternity Hospital, Ireland
Royal College of Surgeons, Ireland
Information provided by (Responsible Party):
University College Dublin

Brief Summary:
A study of aspirin use in pregnancy to prevent high blood pressure and growth restriction of the fetus

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-armed parallel, multi-center, open-label randomised control trial
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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
Other Names:
  • Nu-Seals 75
  • 75 mg aspirin

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
Other Names:
  • Nu-Seals 75
  • 75 mg aspirin




Primary Outcome Measures :
  1. 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)

  2. Adherence to aspirin if prescribed [ Time Frame: 36 weeks ]
    Rate of adherence among study subjects prescribed aspirin.

  3. 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).

  4. 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).

  5. Attendance at study visits [ Time Frame: 36 weeks ]
    Rate of attendance of study visits by study subjects

  6. 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

  7. Any specific study protocol violations [ Time Frame: 36 weeks ]
    Proportion of study subjects for which protocol violations are recorded


Secondary Outcome Measures :
  1. The rate of pre-eclampsia as defined by the International Society for the Study of Pre-eclampsia in Pregnancy. [ Time Frame: Childbirth ]
  2. The rate of fetal growth restriction. [ Time Frame: Childbirth ]
  3. Spontaneous or iatrogenic delivery. [ Time Frame: Prior to 34 and 37 completed weeks of gestation ]
  4. 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.

  5. 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".

  6. 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.

  7. 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"

  8. 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"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility will be assessed based on first pregnancy status.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Ireland
National Maternity Hospital
Dublin, Ireland
Rotunda Hospital
Dublin, Ireland
Sponsors and Collaborators
University College Dublin
Perinatal Ireland
National Maternity Hospital, Ireland
Royal College of Surgeons, Ireland

Publications:
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Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT03674606     History of Changes
Other Study ID Numbers: TEST_PILOT_V1
2013-004241-17 ( EudraCT Number )
ISRCTN15191778 ( Registry Identifier: ISRCTN )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University College Dublin:
Aspirin
low-dose aspirin
Pre-eclampsia
Fetal Medicine Foundation
FMF screening
First trimester
Placental disease
nulliparous
LDA
fetal growth restriction
trans-abdominal uterine artery doppler examination

Additional relevant MeSH terms:
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Aspirin
Pre-Eclampsia
Eclampsia
Fetal Growth Retardation
Placenta Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics