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PreeclampsiaPhase 4NCT05221164

162 mg of Aspirin for Prevention of Preeclampsia

A Phase 4 study testing Aspirin 162 mg in people with Preeclampsia, run by Methodist Medical Center of Illinois at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Preeclampsia
What is being tested?
Aspirin 162 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
6 Jul 2021to 9 Jun 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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Any pregnant patient at Peoria FMC
  • Hx of pre-eclampsia
  • Multifetal gestation
  • Chronic hypertension
  • Type 1 or 2 diabetes
  • Autoimmune disease
Show all 13Show fewer
  • Renal disease
  • Nulliparity
  • Obesity
  • Family Hx of pre-eclampsia
  • Sociodemographic characteristics
  • Age >= 35 years of age
  • Personal history factors (LBW, SGA, > 10-year pregnancy interval, adverse pregnancy outcomes

Who cannot join

  • At high risk of side effects from ASA therapy
  • Hx of hemorrhagic stroke
  • Hx of GI bleed, G6PD
  • Liver disease
  • NSAID or Salicylate allergy)
  • Patients confirmed to be not compliant with therapy

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • UnityPoint Clinic Family Medicine

    Peoria, Illinois, 61602

    Paul Goldsmith, MD, 816-838-8335, paul.goldsmith@unitypoint.org

    Andras Eder, MD, 619-995-2529, andras.eder@unitypoint.org

    Recruiting

Other trials in United States

About this study

This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.

Read the detailed description

After screening to meet inclusion criteria, pregnant patients at the Family Medicine Clinic will be asked to take 162 mg aspirin daily for 6 months, starting at about 12 weeks gestation and continued until the end of pregnancy. They will be monitored every 4 weeks until week 28, then every 2 weeks until week 36, and then weekly from week 36 on. Participants will be screened at these visits for medication compliance (taking, missed doses, side effects, etc). Patients will be subject to lab work as is routinely indicated for preeclampsia.

At the end of the study period, accumulated study data will be compared with historical data from the Family Medicine Clinic on rates of preeclampsia and outcomes in patients taking 81 mg for preeclampsia prevention.

Conditions
Preeclampsia
Being tested
Aspirin 162 mg
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 162 mgDrug

    Also called Aspirin

    Daily aspirin 162 mg during pregnancy to prevent preeclampsia

Study groups in NCT05221164
Study groupRoleWhat they receive
Intervention with 162 mg aspirinExperimentalAspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic
Receives: Drug: Aspirin 162 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with preeclampsia

    Dangerous pregnancy complication characterized by high blood pressure

    Measured: Through study completion, estimated 18 months

  2. Number of participants with eclampsia

    new onset of seizures in pregnant woman with preeclampsia

    Measured: Anytime during pregnancy and 3 months post partum

Secondary outcomes (5)

  1. Number of participants with placental abruption

    Separation of placenta from the uterus prior to delivery

    Measured: Through study completion, estimated 18 months

  2. Number of participants with post partum hemorrhage

    blood loss after delivery

    Measured: Through study completion, estimated 18 months

  3. Number of participants with aplastic anemia

    deficiency of all blood cell lines

    Measured: Through study completion, estimated 18 months

  4. Number of participants with agranulocytosis

    deficiency of granulocytes

    Measured: Through study completion, estimated 18 months

  5. Number of participants with anaphylaxis

    serious allergic reaction

    Measured: Through study completion, estimated 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start6 Jul 2021
  3. Primary completion9 Jun 2022 (estimated)
  4. Study completion9 Jun 2022 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05221164
Sponsor's protocol ID
1732470-3
Status last verified
Jan 2022
First submitted
23 Aug 2021
Last updated
2 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD for statistical analysis and study report.

Publications

  • ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.

    PubMed 29939940

  • Rolnik DL, Wright D, Poon LCY, Syngelaki A, O'Gorman N, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Nicolaides KH. ASPRE trial: performance of screening for preterm pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Oct;50(4):492-495. doi: 10.1002/uog.18816. Epub 2017 Aug 24.

    PubMed 28741785

  • Atallah A, Lecarpentier E, Goffinet F, Doret-Dion M, Gaucherand P, Tsatsaris V. Aspirin for Prevention of Preeclampsia. Drugs. 2017 Nov;77(17):1819-1831. doi: 10.1007/s40265-017-0823-0.

    PubMed 29039130

  • Duley L, Meher S, Hunter KE, Seidler AL, Askie LM. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD004659. doi: 10.1002/14651858.CD004659.pub3.

    PubMed 31684684

  • Kumar N, Das V, Agarwal A, Pandey A, Agrawal S, Singh A. Pilot Interventional Study Comparing Fetomaternal Outcomes of 150 mg Versus 75 mg Aspirin Starting Between 11 and 14 Weeks of Pregnancy in Patients with High Risk of Preeclampsia: A Randomized Control Trial. J Obstet Gynaecol India. 2020 Feb;70(1):23-29. doi: 10.1007/s13224-019-01277-5. Epub 2019 Sep 20.

    PubMed 32030002

  • Levy G. Clinical pharmacokinetics of aspirin. Pediatrics. 1978 Nov;62(5 Pt 2 Suppl):867-72.

    PubMed 724339

  • Needs CJ, Brooks PM. Clinical pharmacokinetics of the salicylates. Clin Pharmacokinet. 1985 Mar-Apr;10(2):164-77. doi: 10.2165/00003088-198510020-00004.

    PubMed 3888490

  • Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15.

    PubMed 27640943

  • Rolnik DL, Nicolaides KH, Poon LC. Prevention of preeclampsia with aspirin. Am J Obstet Gynecol. 2022 Feb;226(2S):S1108-S1119. doi: 10.1016/j.ajog.2020.08.045. Epub 2020 Aug 21.

    PubMed 32835720

  • Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

    PubMed 28657417

  • Seidler AL, Askie L, Ray JG. Optimal aspirin dosing for preeclampsia prevention. Am J Obstet Gynecol. 2018 Jul;219(1):117-118. doi: 10.1016/j.ajog.2018.03.018. Epub 2018 Mar 26. No abstract available.

    PubMed 29588190

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin 162 mg in people with Preeclampsia, run by Methodist Medical Center of Illinois 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 13 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 2 Feb 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with preeclampsia (time frame: Through study completion, estimated 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05221164, which also lists 11 linked publications.

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 2 Feb 2022.

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