Clinical Trial Results:
An Open-Label Randomized-Controlled Trial of Early Screening Test For Pre-Eclampsia and Growth restriction : A Pilot Study (TEST Study)
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Summary
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EudraCT number |
2013-004241-17 |
Trial protocol |
IE |
Global end of trial date |
11 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Feb 2019
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First version publication date |
20 Feb 2019
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Other versions |
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Summary report(s) |
Trial of feasibility and acceptability of routine low-dose aspirin versus Early Screening Test indicated aspirin for pre-eclampsia prevention (TEST study): a multicentre randomised controlled trial An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and growth restriction (TEST): Trial protocol |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TEST_PILOT_V1
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Additional study identifiers
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ISRCTN number |
ISRCTN15191778 | ||
US NCT number |
NCT03674606 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University College Dublin
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Sponsor organisation address |
Belfield, Dublin, Ireland,
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Public contact |
Clinical Research Centre, University College Dublin, 353 017164593, rabia.hussain@ucd.ie
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Scientific contact |
Clinical Research Centre, University College Dublin, 353 017164593, rabia.hussain@ucd.ie
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Apr 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Apr 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To Determine :
1. Proportion of eligible women who agree to participate in the pilot study of a three arm randomised controlled trial
2. Compliance with the study protocol
3. Proportion of women in whom it was possible to obtain trans- abdominal uterine artery Doppler at 14 weeks gestation
4. Proportion of women with completed screening test that are issued the screening result within one week of the test.
5. The acceptability of undergoing a screening test and or of taking aspirin to women in their first pregnancy
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Protection of trial subjects |
Safety Assessment
The following safety evaluations will be performed during the study: adverse event monitoring, vital signs, physical examination, and laboratory assessments.
Vulnerable subjects
Our study will not include incapacitated adults or minors in line with inclusion criteria therefore this area in non-applicable.
Overdose of study treatment
Overdose of a study treatment must first be reported to the sponsor in the first instance as a potential serious adverse event and recorded on the case report form. If double the dose is taken a period of self-observation is adequate. If more than two tablets are taken medical attention must be sought, vital signs checked and fetal monitoring performed with the proceeding dose omitted.
Concomitant therapy
Any medications that are considered necessary for the participant’s welfare and will not interfere with the study medication or pregnancy will be given at the discretion of the Investigator. A record of all medication taken by research participants in the month before visit 1 and concomitant medication a research participant takes throughout the study will be recorded on the appropriate page of the Case Report Form. Participants cannot partake in any other studies when involved in TEST.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Ireland: 557
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Worldwide total number of subjects |
557
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EEA total number of subjects |
557
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
557
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects (pregnant women only) were recruited in the period between 08/05/2014 and 01/02/2016 from the National Maternity Hospital, Dublin, Ireland and the Rotunda Hospital, Dublin, Ireland. Prospective consent for study participation was obtained. | ||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Inclusion criteria: Nulliparous, English-speaking women with singleton pregnancy. Excluded were first-trimester foetal abnormalities, major risk group for pre-eclampsia or fetal growth restriction for which low-dose aspirin was indicated, <18 year olds, concurrently participating in other trials and subjects with contraindications to aspirin. | ||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Blinding implementation details |
This was an open label trial, both the research participants and the investigators were aware of the trial arm to which the research participant had been randomly allocated.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Low-dose aspirin (Group 1) | ||||||||||||||||||||||||||||
Arm description |
Subjects in the routine low-dose aspirin group were randomised to be having standard antenatal care as well as to be taking low dose aspirin from booking (11-13 + 6 weeks) until 36-week gestation orally once daily, as prescribed by the research clinician. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Aspirin Acetylsalycylic Acid
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Investigational medicinal product code |
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Other name |
Nu‐Seals
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation
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Arm title
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No aspirin (Group 2) | ||||||||||||||||||||||||||||
Arm description |
The no aspirin group were randomised to not be receiving aspirin but participation in all of the study ultrasound scans and blood tests were planned. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Screen and treat (Group 3) | ||||||||||||||||||||||||||||
Arm description |
Subjects in the screen and treat arm were randomised to have the results from fetal medicine foundation screening test for pre-eclampsia prospectively revealed. Based upon the results of screening test components, the risk of developing any pre‐eclampsia until 42-week gestation, set at a false positive rate of 5% was used to determine a subject at high risk. These subjects were subsequently allocated to Group 3A if their risk >1:8 and were to commence a course of low-dose aspirin (75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation). Subjects allocated to Group 3B had a <1:8 risk of developing pre-eclampsia and were not to be taking aspirin. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Aspirin Acetylsalycylic Acid
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Investigational medicinal product code |
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Other name |
Nu‐Seals
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation
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Period 2
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Period 2 title |
Period 2
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Blinding implementation details |
This was an open label trial, both the research participants and the investigators were aware of the trial arm to which the research participant had been randomly allocated.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Low-dose aspirin (Group 1) | ||||||||||||||||||||||||||||
Arm description |
Subjects randomized to the routine low-dose aspirin group had standard antenatal care as well as taking low dose aspirin from booking (11-13 + 6 weeks) until 36-week gestation orally once daily, as prescribed by the research clinician. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Aspirin Acetylsalycylic Acid
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Investigational medicinal product code |
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Other name |
Nu‐Seals
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation
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Arm title
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No aspirin (Group 2) | ||||||||||||||||||||||||||||
Arm description |
The no aspirin group did not receive aspirin but did participate in all of the study ultrasound scans and blood tests. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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High-risk screen and treat (Group 3A) | ||||||||||||||||||||||||||||
Arm description |
This group contains subjects that were assessed to have a risk > 1:8 for pre-eclampsia on the scale of the fetal medicine foundation screening test. This subjects commenced a course of low-dose aspirin (75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation). | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Aspirin Acetylsalycylic Acid
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Investigational medicinal product code |
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Other name |
Nu‐Seals
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation
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Arm title
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Low-risk screen and treat (Group 3B) | ||||||||||||||||||||||||||||
Arm description |
This group contains subjects assessed to have a risk < 1:8 for pre-eclampsia on the scale of the fetal medicine foundation screening test and were not given the IMP. | ||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Low-dose aspirin (Group 1)
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Reporting group description |
Subjects in the routine low-dose aspirin group were randomised to be having standard antenatal care as well as to be taking low dose aspirin from booking (11-13 + 6 weeks) until 36-week gestation orally once daily, as prescribed by the research clinician. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
No aspirin (Group 2)
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Reporting group description |
The no aspirin group were randomised to not be receiving aspirin but participation in all of the study ultrasound scans and blood tests were planned. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Screen and treat (Group 3)
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Reporting group description |
Subjects in the screen and treat arm were randomised to have the results from fetal medicine foundation screening test for pre-eclampsia prospectively revealed. Based upon the results of screening test components, the risk of developing any pre‐eclampsia until 42-week gestation, set at a false positive rate of 5% was used to determine a subject at high risk. These subjects were subsequently allocated to Group 3A if their risk >1:8 and were to commence a course of low-dose aspirin (75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation). Subjects allocated to Group 3B had a <1:8 risk of developing pre-eclampsia and were not to be taking aspirin. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Low-dose aspirin (Group 1)
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Reporting group description |
Subjects in the routine low-dose aspirin group were randomised to be having standard antenatal care as well as to be taking low dose aspirin from booking (11-13 + 6 weeks) until 36-week gestation orally once daily, as prescribed by the research clinician. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||
Reporting group title |
No aspirin (Group 2)
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Reporting group description |
The no aspirin group were randomised to not be receiving aspirin but participation in all of the study ultrasound scans and blood tests were planned. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||
Reporting group title |
Screen and treat (Group 3)
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Reporting group description |
Subjects in the screen and treat arm were randomised to have the results from fetal medicine foundation screening test for pre-eclampsia prospectively revealed. Based upon the results of screening test components, the risk of developing any pre‐eclampsia until 42-week gestation, set at a false positive rate of 5% was used to determine a subject at high risk. These subjects were subsequently allocated to Group 3A if their risk >1:8 and were to commence a course of low-dose aspirin (75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation). Subjects allocated to Group 3B had a <1:8 risk of developing pre-eclampsia and were not to be taking aspirin. | ||
Reporting group title |
Low-dose aspirin (Group 1)
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Reporting group description |
Subjects randomized to the routine low-dose aspirin group had standard antenatal care as well as taking low dose aspirin from booking (11-13 + 6 weeks) until 36-week gestation orally once daily, as prescribed by the research clinician. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||
Reporting group title |
No aspirin (Group 2)
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Reporting group description |
The no aspirin group did not receive aspirin but did participate in all of the study ultrasound scans and blood tests. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||
Reporting group title |
High-risk screen and treat (Group 3A)
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Reporting group description |
This group contains subjects that were assessed to have a risk > 1:8 for pre-eclampsia on the scale of the fetal medicine foundation screening test. This subjects commenced a course of low-dose aspirin (75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation). | ||
Reporting group title |
Low-risk screen and treat (Group 3B)
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Reporting group description |
This group contains subjects assessed to have a risk < 1:8 for pre-eclampsia on the scale of the fetal medicine foundation screening test and were not given the IMP. | ||
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End point title |
Eligible women that agree to participate in the study [1] | |||||
End point description |
The proportion of eligible women that agree to participate in the study – this is reflected as a proportion of the number of women approached at the screening stage (feasibility).
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End point type |
Primary
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End point timeframe |
1 year and 11 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
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| No statistical analyses for this end point | ||||||
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End point title |
Adherence to aspirin based on diary cards [2] | |||||||||||||||||||||||||||||||||
End point description |
The number of subjects on low-dose aspirin that adhere to the intervention based on diary cards
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End point type |
Primary
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End point timeframe |
1 year and 11 months
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Adherence to aspirin based on tablet counts [3] | |||||||||||||||||||||||||||||||||
End point description |
The number of subjects on low-dose aspirin that adhere to the intervention based on diary cards
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End point type |
Primary
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End point timeframe |
1 year and 11 months
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Attendance at study visits [4] | |||||
End point description |
Number of subjects included in the trial that attend all study visits
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End point type |
Primary
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End point timeframe |
1 year and 11 months
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
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| No statistical analyses for this end point | ||||||
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End point title |
Satisfactory collection of all endpoints and variables [5] | |||||
End point description |
Number of subjects from whom all endpoints and variables were collected
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End point type |
Primary
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End point timeframe |
1 year and 11 months
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
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| No statistical analyses for this end point | ||||||
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End point title |
Study protocol violations [6] | ||||
End point description |
The number of protocol violations recorded
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End point type |
Primary
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End point timeframe |
1 year and 11 months
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
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| No statistical analyses for this end point | |||||
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End point title |
Number of subjects from whom it was possible to obtain trans-abdominal uterine artery Doppler at 14 weeks gestation. [7] | |||||
End point description |
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End point type |
Primary
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End point timeframe |
1 year and 11 months
|
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
||||||
|
||||||
| No statistical analyses for this end point | ||||||
|
|||||||||||
End point title |
Proportion of women with a completed fetal medicine foundation screening test who are issued the screening result within one week of having the test performed [8] [9] | ||||||||||
End point description |
|||||||||||
End point type |
Primary
|
||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||
| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: No hypothesis tests were performed as the goals of this pilot trial were to provide estimates of feasibility and acceptability. |
|||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||||||||
End point title |
The rate of pre-eclampsia as defined by the International Society for the Study of Pre-eclampsia in Pregnancy. | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Rate of foetal growth restriction | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Spontaneous or iatrogenic delivery prior to 34 and 37 completed weeks gestation. | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
The rate of admission to the neonatal intensive care unit. | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
The rate of placental abruption, any reported death (stillbirth, neonatal or infant death) and small for gestational age infants. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Acceptability questionnaire: Aspirin was easy to swallow | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Acceptability questionnaire: With regards the screening test I found it | ||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Acceptability questionnaire: Reason aspirin missed. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Acceptability questionnaire: In a future pregnancy I would | ||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
1 year and 11 months
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
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Adverse events information
|
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Timeframe for reporting adverse events |
From study enrollment until 28-days post-delivery.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
|
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Reporting groups
|
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Reporting group title |
Low-dose aspirin (Group 1)
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Reporting group description |
Subjects randomized to the routine low-dose aspirin group had standard antenatal care as well as taking low dose aspirin from booking (11-13 + 6 weeks) until 36-week gestation orally once daily, as prescribed by the research clinician. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
No aspirin (Group 2)
|
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Reporting group description |
The no aspirin group did not receive aspirin but did participate in all of the study ultrasound scans and blood tests. All subjects had a recruitment visit involving the first-trimester fetal medicine foundation screening test for pre-eclampsia, the results of which were not revealed to the subjects. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Screen and treat (Group 3)
|
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Reporting group description |
For this arm the results from fetal medicine foundation screening test for pre-eclampsia were prospectively revealed. Based upon the results of screening test components, the risk of developing any pre‐eclampsia until 42-week gestation, set at a false positive rate of 5% was used to determine a subject at high risk. These subjects were subsequently allocated to Group 3A if their risk >1:8 and commenced a course of low-dose aspirin (75 mg taken once daily by oral ingestion from 11‐13 + 6 to 36 weeks gestation). Subjects allocated to Group 3B had a <1:8 risk of developing pre-eclampsia and did not take aspirin. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
