PreeclampsiaPhase 4NCT05514847
Low Dose Aspirin for Preterm Preeclampsia Preventionmg/day Dose in High-risk Patients
A Phase 4 study testing Aspirin 81Mg Ec Tab and Aspirin 162Mg Ec Tab in people with Preeclampsia and Pregnancy Related, run by University of Virginia at 1 site in United States.
Trial summary
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Pregnancy Related
- What is being tested?
- Aspirin 81Mg Ec Tab and Aspirin 162Mg Ec Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Ages 18-50
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Pregnant female in the first trimester.
- Ability to take oral medication and be willing to adhere to the aspirin regimen
- Patient has a prenatal ultrasound between 11+0 through 13+6 days of gestation
- Patient who has low or high risks for preeclampsia by the ACOG (American College of Obstetricians and Gynecologists) screening tool, and low or high risks for the FMF prescreening tool for preeclampsia.
Who cannot join
- ASA allergy, known hypersensitivity to NSAIDS
- Patients with nasal polyps
- Patients with aspirin-induced asthma exacerbations
- Active peptic ulcer disease
- Severe hepatic dysfunction
- History of GI bleeding
Show all 10Show fewer
- Pregnancy with major abnormalities demonstrated on the 11-13-week scan
- Patient presents beyond 13w6d for first prenatal visit
- Age < 18
- Non-viable pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Low Dose Aspirin for Preterm Preeclampsia Prevention - a Randomized Trial of 81 Vs 162 Mg/day Dose in High-risk Patients
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.
Read the detailed description
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily ASA use. Currently, all patients that present to UVA Obstetric clinics are evaluated for development of preeclampsia per the current ACOG guidelines. If they screen positive per ACOG guidelines, then it is recommended they initiate 81mg/day ASA starting at 12 weeks of pregnancy and continuing until delivery. For this study, patients that present for early first trimester ultrasound (US) (for dating and/or genetic testing + ultrasound) will be offered enrollment in the study, and consenting patients will undergo double screening tests with ACOG and the FMF-based preeclampsia screen. This test will include first trimester uterine artery PI, assessment of maternal blood pressure, a maternal history and maternal serum markers including PAPP-A, PLGF, S-FLT, AFP. The first trimester preeclampsia screen will be performed between 10 weeks, 0 days and 13 weeks, 6 days of pregnancy.
For the patients within the intervention group, repeat uterine artery PI measurements will be performed during the patient's 20-week anatomic survey ultrasound. Repeat maternal serum biomarkers will be collected with routine 28-week labs and at time of delivery (standard times for blood draws in pregnancy) for all enrolled patients. Patients will be followed longitudinally through their pregnancy and delivery and neonatal outcomes will be recorded. Delivery and timing of delivery will be based solely on obstetric indications regardless of status in the trial. All uterine artery Doppler measurements will be obtained by P.J. Kumar.
- Conditions
- Preeclampsia, Pregnancy Related
- Being tested
- Aspirin 81Mg Ec Tab, Aspirin 162Mg Ec Tab
- 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 81Mg Ec TabDrug
81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy
Aspirin 162Mg Ec TabDrug
162 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 1 Control Group | No intervention | Control Group (Group 1): These patients will be screened negative for both the ACOG screening test and the FMF preeclampsia screen. These women will receive no aspirin. |
| 2 Randomized Group 1 | Active comparator | Group 2: These patients will be screened negative for the ACOG screening test but positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin. Receives: Drug: Aspirin 81Mg Ec Tab; Drug: Aspirin 162Mg Ec Tab |
| 3 Standard of Care Group | Other | Group 3: These patients will be screened positive for the ACOG screening test but negative for the FMF preeclampsia screen. These women will be offered 81 mg aspirin, which is the standard of care. Receives: Drug: Aspirin 81Mg Ec Tab |
| Group 4 Randomized Group 2 | Active comparator | Group 4: These patients will be screened negative for the ACOG screening test and positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin. Receives: Drug: Aspirin 81Mg Ec Tab; Drug: Aspirin 162Mg Ec Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of 81mg/day vs 162 mg/day aspirin on PAPP-A
To assess the effect of 81mg/day vs 162mg/day on the progression of PAPP-A in pregnancy. Unit of measure is multiples of the median (MoM).
Measured: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81mg/day vs 162 mg/day aspirin on PGLF (Placenta growth factor)
To assess the effect of 81mg/day vs 162mg/day on the progression of PGLF in pregnancy. Unit of measure is multiples of the median (MoM).
Measured: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81mg/day vs 162 mg/day aspirin on S-FLT
To assess the effect of 81mg/day vs 162mg/day on the progression of S-FLT in pregnancy. Unit of measure is multiples of the median (MoM).
Measured: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81mg/day vs 162 mg/day aspirin on AFP (alpha fetal protein)
To assess the effect of 81mg/day vs 162mg/day on the progression of AFP in pregnancy. Unit of measure is multiples of the median (MoM).
Measured: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
Secondary outcomes (3)
The impact of 81 mg/day vs 162 mg/day aspirin dosage on Uterine artery pulsatility average in patients with 81 vs 162 mg/day of ASA
The uterine artery pulsaltility index will be reviewed. This will be obtained via doppler ultrasound studies This will be described on a continuous scale with repeated measures and analyzed using T-test and ANOVA. Uterine artery doppler pulsatile index (PI) will be measured in the first, second and third trimester of pregnancy using doppler mode on the ultrasound
We will use these data to determine the ability to predict adverse outcomes by uterine artery Doppler parameters and mean arterial pressure. We predict that the uterine artery PI will be lower in the 162mg/day group compared to the 81mg/day group. Furthermore, uterine artery PI will increase in those that are at high risk of developing PE compared to the control group.
Measured: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81 mg/day vs 162 mg/day aspirin on maternal outcomes
Maternal outcomes including:
- Mode of delivery
- Antepartum stillbirth
- Pre-pregnancy medical conditions
- hemorrhage
- Abruption
- Development of fetal growth restriction (FGR)
- Develop of hypertensive disorder of pregnancy
- Post-partum blood pressure and medication adjustments
- oligohydramnios, polyhydramnios,
- gestational age at delivery
- blood pressure at delivery
- labor course including need for magnesium
Measured: from before 14 weeks gestation age through delivery and resolution of any pregnancy and delivery-related illnesses (up to 6 weeks postpartum)
The impact of 81 mg/day vs 162 mg/day aspirin on fetal outcomes
Fetal outcomes including:
- Gestational age (GA) at time of delivery
- Neonatal intensive care unit (NICU) length of stay
- Estimated fetal weight compared to birth weight
- Intrapartum stillbirth
- Need for fetal interventions including: mechanical ventilation, CPAP
- Apgar scores at 1,5 minutes
- Arterial cord pH
- Intraventricular hemorrhage (IVH), Necrotizing enterocolitis (NEC), sepsis, neonatal death, neonatal seizures, neonatal end organ dysfunction, fetal anemia
Measured: from before 14 weeks gestation age through discharge from hospital following delivery (up to 6 weeks post birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2025 (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.
- More trials run by University of VirginiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into 1 of 4 groups based on their results of two screening tests for preeclampsia.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher S. Ennen, University of Virginia
- Investigators
- Priyanka Kumar, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514847
- Sponsor's protocol ID
- HSR220148
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Aspirin for Preterm Preeclampsia Prevention - a Randomized Trial of 81 Vs 162 Mg/day Dose in High-risk Patients
- ClinicalTrials.gov ID
- NCT05514847
- Acronym / sponsor ID
- HSR220148
- Conditions
- Preeclampsia, Pregnancy Related
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Aug 2022 (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 will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.
Detailed description
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily ASA use. Currently, all patients that present to UVA Obstetric clinics are evaluated for development of preeclampsia per the current ACOG guidelines. If they screen positive per ACOG guidelines, then it is recommended they initiate 81mg/day ASA starting at 12 weeks of pregnancy and continuing until delivery. For this study, patients that present for early first trimester ultrasound (US) (for dating and/or genetic testing + ultrasound) will be offered enrollment in the study, and consenting patients will undergo double screening tests with ACOG and the FMF-based preeclampsia screen. This test will include first trimester uterine artery PI, assessment of maternal blood pressure, a maternal history and maternal serum markers including PAPP-A, PLGF, S-FLT, AFP. The first trimester preeclampsia screen will be performed between 10 weeks, 0 days and 13 weeks, 6 days of pregnancy.
For the patients within the intervention group, repeat uterine artery PI measurements will be performed during the patient's 20-week anatomic survey ultrasound. Repeat maternal serum biomarkers will be collected with routine 28-week labs and at time of delivery (standard times for blood draws in pregnancy) for all enrolled patients. Patients will be followed longitudinally through their pregnancy and delivery and neonatal outcomes will be recorded. Delivery and timing of delivery will be based solely on obstetric indications regardless of status in the trial. All uterine artery Doppler measurements will be obtained by P.J. Kumar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be randomized into 1 of 4 groups based on their results of two screening tests for preeclampsia.
| Arm | Type | Receives |
|---|---|---|
| 1 Control Group | No intervention | –Control Group (Group 1): These patients will be screened negative for both the ACOG screening test and the FMF preeclampsia screen. These women will receive no aspirin. |
| 2 Randomized Group 1 | Active comparator | Drug: Aspirin 81Mg Ec Tab, Drug: Aspirin 162Mg Ec TabGroup 2: These patients will be screened negative for the ACOG screening test but positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin. |
| 3 Standard of Care Group | Other | Drug: Aspirin 81Mg Ec TabGroup 3: These patients will be screened positive for the ACOG screening test but negative for the FMF preeclampsia screen. These women will be offered 81 mg aspirin, which is the standard of care. |
| Group 4 Randomized Group 2 | Active comparator | Drug: Aspirin 81Mg Ec Tab, Drug: Aspirin 162Mg Ec TabGroup 4: These patients will be screened negative for the ACOG screening test and positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Ages 18-50
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Pregnant female in the first trimester.
- Ability to take oral medication and be willing to adhere to the aspirin regimen
Key exclusion criteria (10 listed)
- ASA allergy, known hypersensitivity to NSAIDS
- Patients with nasal polyps
- Patients with aspirin-induced asthma exacerbations
- Active peptic ulcer disease
- Severe hepatic dysfunction
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 81Mg Ec Tab81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy | Drug | 2 Randomized Group 1, 3 Standard of Care Group, Group 4 Randomized Group 2 |
| Aspirin 162Mg Ec Tab162 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy | Drug | 2 Randomized Group 1, Group 4 Randomized Group 2 |
Primary outcome
The impact of 81mg/day vs 162 mg/day aspirin on PAPP-A
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of PAPP-A in pregnancy. Unit of measure is multiples of the median (MoM).
The impact of 81mg/day vs 162 mg/day aspirin on PGLF (Placenta growth factor)
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of PGLF in pregnancy. Unit of measure is multiples of the median (MoM).
The impact of 81mg/day vs 162 mg/day aspirin on S-FLT
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of S-FLT in pregnancy. Unit of measure is multiples of the median (MoM).
The impact of 81mg/day vs 162 mg/day aspirin on AFP (alpha fetal protein)
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of AFP in pregnancy. Unit of measure is multiples of the median (MoM).
3 secondary outcomes
The impact of 81 mg/day vs 162 mg/day aspirin dosage on Uterine artery pulsatility average in patients with 81 vs 162 mg/day of ASA
Time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
The impact of 81 mg/day vs 162 mg/day aspirin on maternal outcomes
Time frame: from before 14 weeks gestation age through delivery and resolution of any pregnancy and delivery-related illnesses (up to 6 weeks postpartum)
The impact of 81 mg/day vs 162 mg/day aspirin on fetal outcomes
Time frame: from before 14 weeks gestation age through discharge from hospital following delivery (up to 6 weeks post birth)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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.
Priyanka Kumar principal investigator
University of Virginia
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 Aspirin 81Mg Ec Tab and Aspirin 162Mg Ec Tab in people with Preeclampsia and Pregnancy Related, run by University of Virginia 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
The impact of 81mg/day vs 162 mg/day aspirin on PAPP-A (time frame: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)). The study lists 4 primary outcomes in all. 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 15 Jan 2025.