Pre-EclampsiaPhase 4NCT04656665
The Effectiveness of Aspirin on Preventing Pre-eclampsia
A Phase 4 study testing Aspirin in people with Pre-Eclampsia, run by The Third Affiliated Hospital of Guangzhou Medical University.
Trial summary
This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2021to 31 Dec 2022
- Phase
- Phase 4
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-55 years
- Gestational age between 12-20 weeks of pregnancy
- High risk of developing pre-eclampsia
- At least one of the following risk factors: Pre-eclampsia in a previous pregnancy , Multiple pregnancy，Diabetes Mellitus(Type 1 or 2), Chronic Hypertension，Renal disease, Autoimmune disease.
- At least two of the following risk factors: Primiparity，Pre-pregnancy Body Mass Index ≥28kg/m2, Age ≥35 years, Family members have a history of pre-eclampsia.
- Maternal informed conset obtained
Who cannot join
- Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
- Patient with known intention to terminate pregnancy
- Fetal abnormalities detected （including but not limited to major fetal malformation and FGR）
- Severe heart, liver, renal disease who can not burden the experiment
- Alcohol and drug abuse
- Being in another drug experiment within 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.
Read the detailed description
Currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.
- Conditions
- Pre-Eclampsia
- Being tested
- Aspirin
- Keywords
- Pre-eclampsia, Aspirin
- 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
Also called Acetylsalicylic acid
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 75mg | Experimental | Take 75mg of aspirin daily in tihis group Receives: Drug: Aspirin |
| 100mg | Active comparator | Take 100mg of aspirin daily in this group Receives: Drug: Aspirin |
| blank | No intervention | Not taking aspirin in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pre-eclampsia
Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group
Measured: 1 year
Secondary outcomes (4)
Preterm birth
Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
Measured: 1 year
Fetal growth restriction
Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group
Measured: 1 year
Placental abruption 4/5000 Placental abruption
Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
Measured: 1 year
Postpartum hemorrhage
Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start15 Mar 2021 (estimated)
- Primary completion14 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656665
- Sponsor's protocol ID
- ThirdGuangzhouMU
- Status last verified
- Mar 2021
- First submitted
- 11 Nov 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
- ClinicalTrials.gov ID
- NCT04656665
- Acronym / sponsor ID
- ThirdGuangzhouMU
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-eclampsia, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 14 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Dec 2020 (actual)
- 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.
This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.
Detailed description
Currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 75mg | Experimental | Drug: AspirinTake 75mg of aspirin daily in tihis group |
| 100mg | Active comparator | Drug: AspirinTake 100mg of aspirin daily in this group |
| blank | No intervention | –Not taking aspirin in this group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-55 years
- Gestational age between 12-20 weeks of pregnancy
- High risk of developing pre-eclampsia
- Maternal informed conset obtained
Key exclusion criteria (6 listed)
- Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
- Patient with known intention to terminate pregnancy
- Fetal abnormalities detected （including but not limited to major fetal malformation and FGR）
- Severe heart, liver, renal disease who can not burden the experiment
- Alcohol and drug abuse
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic acidFor patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy | Drug | 100mg, 75mg |
Primary outcome
Incidence of pre-eclampsia
Time frame: 1 year
Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group
4 secondary outcomes
Preterm birth
Time frame: 1 year
Fetal growth restriction
Time frame: 1 year
Placental abruption 4/5000 Placental abruption
Time frame: 1 year
Postpartum hemorrhage
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Pre-Eclampsia, run by The Third Affiliated Hospital of Guangzhou Medical University.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang He, Dr. (+86020-81292532, hefangjnu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pre-eclampsia (time frame: 1 year). 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 10 Mar 2021.