PreeclampsiaPhase 4NCT03735433
The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia
A Phase 4 study testing 162mg aspirin dose in people with Preeclampsia, run by Ohio State University at 1 site in United States.
Trial summary
Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- 162mg aspirin dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- BMI at enrollment >/= 30
- plan for ASA for preeclampsia prevention
Who cannot join
- BMI < 30
- already on ASA
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State Medical Center Labor and Delivery Unit
Columbus, Ohio, 43210
About this study
Official title: The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia
Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.
Read the detailed description
Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.
- Conditions
- Preeclampsia
- Being tested
- 162mg aspirin dose
- Keywords
- aspirin, obesity
- Medical subject headings
- Pre-Eclampsia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
162mg aspirin doseDrug
2 pills of 81mg aspirin
| Study group | Role | What they receive |
|---|---|---|
| 81 mg daily aspirin dose | No intervention | obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA |
| 162mg daily aspirin dose | Active comparator | obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA Receives: Drug: 162mg aspirin dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Diagnosis of Preeclampsia
by acog definitions
Measured: Through study completion, an average for 10 months
Secondary outcomes (1)
Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2
incomplete platelet inhibition measured by urinary TBx2
Measured: Through study completion, an average for 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start15 Jan 2019
- Primary completion30 Jan 2023
- Study completion1 Mar 2024
Why it stopped: futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara M Rood, MD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735433
- Sponsor's protocol ID
- OBASA
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2018
- Last updated
- 29 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia
- ClinicalTrials.gov ID
- NCT03735433
- Acronym / sponsor ID
- OBASA
- Conditions
- Preeclampsia
- Keywords
- aspirin, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: futility
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 29 Apr 2024
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 used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.
Detailed description
Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 81 mg daily aspirin dose | No intervention | –obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA |
| 162mg daily aspirin dose | Active comparator | Drug: 162mg aspirin doseobese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI at enrollment >/= 30
- plan for ASA for preeclampsia prevention
Key exclusion criteria (2 listed)
- BMI < 30
- already on ASA
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 |
|---|---|---|
| 162mg aspirin dose2 pills of 81mg aspirin | Drug | 162mg daily aspirin dose |
Primary outcome
Incidence of Diagnosis of Preeclampsia
Time frame: Through study completion, an average for 10 months
by acog definitions
1 secondary outcome
Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2
Time frame: Through study completion, an average for 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Severe Preeclampsia
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 4 study testing 162mg aspirin dose in people with Preeclampsia, run by Ohio State University at 1 site in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Apr 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Diagnosis of Preeclampsia (time frame: Through study completion, an average for 10 months). 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 29 Apr 2024.