NCT04645004CompletedPhase 1/2
Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy
Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy
Source: ClinicalTrials.gov · Last updated 18 Apr 2024
Brief summary (registry, in English)
Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 19 Nov 2020
- Start date
- 29 Dec 2020
- Primary completion date
- 11 Jan 2024
- Lead sponsor
- Thomas Jefferson University
- NCT number
- NCT04645004
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 20
- From 29 Dec 2020 to the primary completion date, 11 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of aspirin therapy prior to enrollment in the current pregnancy
Lab values
- Other known platelet disorder/thrombophilia at enrollment
Other
- Contraindication to aspirin
- Current or planned use of any other anticoagulation
- Current need for dialysis
- Thrombocytopenia (\<150)
Who the study is looking for
- \<16 weeks' gestational age
- Singleton pregnancy
- Plan to take 81mg aspirin due to high risk history (below), but not yet initiated
- ≥1 risk factor:
- Chronic hypertension
- Type I or II diabetes
- Previous preeclampsia
- Renal disease
- Autoimmune disease (SLE) OR
- ≥2 risk factor:
- Nulliparity
- IVF pregnancy
- Black race or socioeconomic disadvantaged
- BMI\>30
- Prior adverse pregnancy outcome
Age in the registry: 13 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.