PreeclampsiaPhase 3NCT06111079
Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia
A Phase 3 study testing aspirin discontinuation and aspirin continuation in people with Preeclampsia and Perinatal Haemorrhage, run by FANG HE at 1 site in China.
Trial summary
Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia, Perinatal Haemorrhage
- What is being tested?
- aspirin discontinuation and aspirin continuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- At <16 weeks of gestation, normal NT scan
- At least 1 high risk factor or at least 2 moderate risk factors
- Intend to receive prenatal examination and deliver in this institution
- Signed a written informed consent for participation in the study
Who cannot join
- Aspirin initiated after 16 week
- Intolerant or allergic to aspirin
- Aspirin adherence was <80%
- Miscarriage or termination of pregnancy before randomization
- drop out (do not return to the hospital for delivery).
- Lost to follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
FANG HE
Guangzhou, Guangdong, 510150
FANG HE, M.D, 13724831279, hefangjnu@126.com
Qingwen Nie, Master, 15622149953, qw0621n@163.com
About this study
Official title: Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial
Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.
Read the detailed description
This study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm PE is not inferior to 36 weeks of gestation. We will include pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors. During 12-16 weeks of gestation, the mean arterial pressure (MAP) and placental growth factor (PlGF) are measured, then initiating aspirin 100mg qn. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sFlt-1 and PlGF were detected at the same time. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. The incidence of preterm PE in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.
- Conditions
- Preeclampsia, Perinatal Haemorrhage
- Being tested
- aspirin discontinuation, aspirin continuation
- Keywords
- low dose aspirin, prevention, preeclampsia, pregnancy outcomes, randomized controlled trial, aspirin discontinuation
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin discontinuationDrug
Also called initiation of aspirin in early pregnancy
Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, discontinuing aspirin at 28 weeks of gestation according to randomization at 24-27+6 weeks of gestation.
aspirin continuationDrug
Also called initiation of aspirin in early pregnancy
Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, continuing aspirin until 36 weeks of gestation according to randomization at 24-27+6 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin discontinuation group | Experimental | initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, discontinuing aspirin at 28 weeks of gestation. Receives: Drug: aspirin discontinuation |
| Control group | Active comparator | initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, continuing aspirin until 36 weeks of gestation. Receives: Drug: aspirin continuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preterm preeclampsia
delivery with preeclampsia before 37 weeks of gestation
Measured: Within one week after delivery
Secondary outcomes (4)
Incidence of early-onset preeclampsia
delivery with preeclampsia before 34 weeks of gestation
Measured: Within one week after delivery
Incidence of term preeclampsia
delivery with preeclampsia after 37 weeks of gestation
Measured: Within one week after delivery
Incidence of gestational hypertension
new onset of high blood pressure after 20 weeks of gestation (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg)
Measured: Within one week after delivery
Incidence of small for gestational age
birth weight below the 10th percentile
Measured: Within one week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Model description
- Pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors are included. Initiating aspirin 100mg qn during 12-16 weeks of gestation. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation.
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FANG HE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FANG HE, The Third Affiliated Hospital of Guangzhou Medical University
- Investigators
- Fang He, M.D, Principal investigator, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111079
- Sponsor's protocol ID
- [2023] Ethics Review NO.118
- Status last verified
- Jul 2024
- First submitted
- 23 Oct 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06111079
- Acronym / sponsor ID
- [2023] Ethics Review NO.118
- Conditions
- Preeclampsia, Perinatal Haemorrhage
- Keywords
- low dose aspirin, prevention, preeclampsia, pregnancy outcomes, randomized controlled trial, aspirin discontinuation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- FANG HEUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Nov 2023 (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.
Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.
Detailed description
This study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm PE is not inferior to 36 weeks of gestation. We will include pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors. During 12-16 weeks of gestation, the mean arterial pressure (MAP) and placental growth factor (PlGF) are measured, then initiating aspirin 100mg qn. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sFlt-1 and PlGF were detected at the same time. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. The incidence of preterm PE in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors are included. Initiating aspirin 100mg qn during 12-16 weeks of gestation. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation.
| Arm | Type | Receives |
|---|---|---|
| Aspirin discontinuation group | Experimental | Drug: aspirin discontinuationinitiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, discontinuing aspirin at 28 weeks of gestation. |
| Control group | Active comparator | Drug: aspirin continuationinitiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, continuing aspirin until 36 weeks of gestation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At <16 weeks of gestation, normal NT scan
- At least 1 high risk factor or at least 2 moderate risk factors
- Intend to receive prenatal examination and deliver in this institution
- Signed a written informed consent for participation in the study
Key exclusion criteria (6 listed)
- Aspirin initiated after 16 week
- Intolerant or allergic to aspirin
- Aspirin adherence was <80%
- Miscarriage or termination of pregnancy before randomization
- drop out (do not return to the hospital for delivery).
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 |
|---|---|---|
| aspirin discontinuationAlso: initiation of aspirin in early pregnancyInitiation of aspirin 100mg qn from 12 to 16 weeks of gestation, discontinuing aspirin at 28 weeks of gestation according to randomization at 24-27+6 weeks of gestation. | Drug | Aspirin discontinuation group |
| aspirin continuationAlso: initiation of aspirin in early pregnancyInitiation of aspirin 100mg qn from 12 to 16 weeks of gestation, continuing aspirin until 36 weeks of gestation according to randomization at 24-27+6 weeks of gestation. | Drug | Control group |
Primary outcome
Incidence of preterm preeclampsia
Time frame: Within one week after delivery
delivery with preeclampsia before 37 weeks of gestation
4 secondary outcomes
Incidence of early-onset preeclampsia
Time frame: Within one week after delivery
Incidence of term preeclampsia
Time frame: Within one week after delivery
Incidence of gestational hypertension
Time frame: Within one week after delivery
Incidence of small for gestational age
Time frame: Within one week after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
Fang He, M.D principal investigator
The Third Affiliated Hospital of Guangzhou Medical University
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 discontinuation and aspirin continuation in people with Preeclampsia and Perinatal Haemorrhage, run by FANG HE at 1 site in China.
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 4 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 3 Jul 2024. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang He, M.D (+86 13724831279, 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 preterm preeclampsia (time frame: Within one week after delivery). 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 3 Jul 2024.