PreeclampsiaPhase 3ASPRENCT02301780
Combined Multi-marker Screening and Treatment With Aspirin for Pre-eclampsia Prevention
A Phase 3 study testing Aspirin in people with Preeclampsia, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Phase III two arm double-blinded randomised controlled trial to examine the effect of prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased risk for PET on the incidence and severity of the disease Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2015to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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, Flemish, Hebrew, Arabic and Russian speaking (otherwise interpreters will be used)
- Informed and written consent.
Who cannot join
- Multiple pregnancies
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Multi-marker Screening and Randomised Patient Treatment With Aspirin for Evidence-based Pre-eclampsia Prevention. University College London - Sponsor of All EU Study Sites.
Phase III two arm double-blinded randomised controlled trial to examine the effect of prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased risk for PET on the incidence and severity of the disease
Read the detailed description
Screening and Prevention of Pre-eclampsia (High Blood Pressure): Randomised Trial of Aspirin Versus Placebo (ASPRE)
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
- Preeclampsia
- Being tested
- Aspirin, Placebo
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
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.
PlaceboDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Placebo Receives: Drug: Placebo |
| Intervention Group | Active comparator | Aspirin Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Pre-eclampsia requiring delivery prior to 37 weeks of gestation
Measured: 24-26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301780
- Sponsor's protocol ID
- 0066-14-RMC
- Acronym
- ASPRE
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2014
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Multi-marker Screening and Randomised Patient Treatment With Aspirin for Evidence-based Pre-eclampsia Prevention. University College London - Sponsor of All EU Study Sites.
- ClinicalTrials.gov ID
- NCT02301780
- Acronym / sponsor ID
- ASPRE / 0066-14-RMC
- Conditions
- Preeclampsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III two arm double-blinded randomised controlled trial to examine the effect of prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased risk for PET on the incidence and severity of the disease
Detailed description
Screening and Prevention of Pre-eclampsia (High Blood Pressure): Randomised Trial of Aspirin Versus Placebo (ASPRE)
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboPlacebo |
| Intervention Group | Active comparator | Drug: AspirinAspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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, Flemish, Hebrew, Arabic and Russian speaking (otherwise interpreters will be used)
Key exclusion criteria (9 listed)
- Multiple pregnancies
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinParticipants 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. | Drug | Intervention Group |
| PlaceboAlso: AspirinParticipants 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. | Drug | Control Group |
Primary outcome
Number of participants with Pre-eclampsia requiring delivery prior to 37 weeks of gestation
Time frame: 24-26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin in people with Preeclampsia, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Pre-eclampsia requiring delivery prior to 37 weeks of gestation (time frame: 24-26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.