Combined Multi-marker Screening and Treatment With Aspirin for Pre-eclampsia Prevention
NCT ID: NCT02301780
Last Updated: 2016-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2 participants
INTERVENTIONAL
2015-12-31
2016-10-31
Brief Summary
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Detailed Description
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Screening: All women with singleton pregnancies undergoing routine screening for aneuploidies will be invited to participate in the screening study for PET.
Interventions: Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.
The maximum duration for aspirin or placebo intake will be 180 days.
Key Inclusion and Exclusion Criteria Inclusion criteria for participant selection for RCT Age \> 18 years, Singleton pregnancies, Live fetus at 11-13 weeks of gestation, High-risk for preterm-PET at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (pregnancy associated plasma protein-A and placental growth factor), English, Italian, Spanish, French, Dutch or Greek speaking (otherwise interpreters will be used), Informed and written consent.
Exclusion criteria Multiple pregnancies, Women taking low-dose aspirin regularly (administration must have ceased \>28days prior to randomisation), Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment, Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness, Bleeding disorders such as Von Willebrand's disease, Peptic ulceration, Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication, Age \< 18 years, Concurrent participation in another drug trial or at any time within the previous 28 days, Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control Group
Placebo
Placebo
Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.
The maximum duration for aspirin or placebo intake will be 180 days.
Intervention Group
Aspirin
Aspirin
Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.
The maximum duration for aspirin or placebo intake will be 180 days.
Interventions
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Aspirin
Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.
The maximum duration for aspirin or placebo intake will be 180 days.
Placebo
Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.
The maximum duration for aspirin or placebo intake will be 180 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancies
* Live fetus at 11-13 weeks of gestation,
* High-risk for preterm-PET at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (pregnancy associated plasma protein-A and placental growth factor),
* English, Italian, Spanish, French, Flemish, Hebrew, Arabic and Russian speaking (otherwise interpreters will be used)
* Informed and written consent.
Exclusion Criteria
* Women taking low-dose aspirin regularly
* Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
* Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness, Bleeding disorders such as Von Willebrand's disease
* Peptic ulceration
* Hypersensitivity to aspirin or already on long term nonsteroidal anti- inflammatory medication
* Age \< 18 years
* Concurrent participation in another drug trial or at any time within the previous 28 days
* Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol
18 Years
FEMALE
Yes
Sponsors
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University College, London
OTHER
Rabin Medical Center
OTHER
Responsible Party
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Locations
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Rabin Medical Center
Petah Tikva, , Israel
Countries
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Other Identifiers
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0066-14-RMC
Identifier Type: -
Identifier Source: org_study_id