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New treatment option for Preeclampsia Postpartum
Official title Postpartum Low-Dose Aspirin and Preeclampsia
ClinicalTrials.gov ID: NCT03667326
What this study is testing
What is Aspirin tablet?
Aspirin tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preeclampsia postpartum.
Also referred to as Aspirin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to find out whether women with severe preeclampsia taking low-dose aspirin (LDA) for 3 weeks post-delivery will experience an improvement in endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as the effects of preeclampsia can persist postpartum. Women diagnosed with severe preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 3 weeks post-delivery.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Singleton or Multiple gestation
- Maternal age \>= 18 years
- 20 0/7 weeks gestation or greater
- Severe Preeclampsia diagnosed prior to delivery
You likely can't join if
- Aspirin use postpartum for other medical indication
- Lovenox, unfractionated heparin, or other anticoagulant use postpartum for an indication other than postoperative (in-house)
- Aspirin use within 7 days of planned initial FMD testing postpartum
- Hypersensitivity or allergy to Aspirin or other salicylates
- Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy
- Nasal polyps
See the full eligibility criteria
- Singleton or Multiple gestation
- Maternal age \>= 18 years
- 20 0/7 weeks gestation or greater
- Severe Preeclampsia diagnosed prior to delivery
- Aspirin use postpartum for other medical indication
- Lovenox, unfractionated heparin, or other anticoagulant use postpartum for an indication other than postoperative (in-house)
- Aspirin use within 7 days of planned initial FMD testing postpartum
- Hypersensitivity or allergy to Aspirin or other salicylates
- Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy
- Nasal polyps
- Gastric or Duodenal ulcers, history of GI bleeding
- Severe hepatic dysfunction
- Bleeding disorders and diathesis
- Breastfeeding a newborn with low platelets (NAIT) For sub-study patients, inclusion and exclusion criteria will be the same, with the exception of diagnosis of severe preeclampsia prior to delivery (exclusion criterion...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.