Actively Recruiting
Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial
Led by FANG HE · Updated on 2024-07-03
1800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the timing of stopping low-dose aspirin affects the prevention of preeclampsia in pregnant women at high risk. Preeclampsia is a pregnancy complication linked to issues with the placenta developing before 28 weeks. The study compares stopping aspirin at 28 weeks versus continuing until 36 weeks to see if stopping earlier is not worse for preventing preterm preeclampsia, which could also lower risks of bleeding and reduce medical costs. Pregnant women with normal early scans and specific risk factors begin taking 100 mg of aspirin daily between 12 and 16 weeks of pregnancy. Around 24 to 28 weeks, participants are randomly assigned to either stop aspirin at 28 weeks or continue until 36 weeks. Researchers measure certain blood markers during this period to monitor the effects. The study tests whether stopping aspirin earlier is almost as effective as the longer treatment. Participants will be assessed for the occurrence of preterm and early-onset preeclampsia, gestational hypertension, and small for gestational age babies within one week after delivery. Blood pressure and placental growth factor levels will be checked early on, and adherence to aspirin use will be monitored. The study lasts through pregnancy until delivery, with follow-up shortly after birth to evaluate outcomes and safety.
CONDITIONS
Brief Title
Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with a normal nuchal translucency scan before 16 weeks of gestation
- Must have at least one high-risk factor or two moderate-risk factors for preeclampsia
- Intend to receive prenatal care and deliver at the study institution
- Provide signed informed consent to participate in the study
You will not qualify if you...
- Aspirin treatment started after 16 weeks of gestation
- Allergic or intolerant to aspirin
- Aspirin adherence less than 80%
- Miscarriage or pregnancy termination before randomization
- Dropped out by not returning for delivery at the hospital
- Lost to follow-up during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 16 weeks of gestation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - From 12-16 weeks to 28 or 36 weeks of gestation depending on group assignment
Participants start aspirin 100mg daily between 12 and 16 weeks of gestation. At 24 to 27+6 weeks of gestation, participants are randomly assigned to either discontinue aspirin at 28 weeks or continue aspirin until 36 weeks of gestation.
Visits at 12-16 weeks, 24-27+6 weeks, and additional visits until 36 weeks depending on aspirin continuation
Duration - Until one week after delivery
Participants are monitored for pregnancy outcomes including incidence of preterm preeclampsia and other related conditions until one week after delivery.
Approximately 1 visit within one week after delivery
Trial Site Locations
Total: 1 location
1
FANG HE
Guangzhou, Guangdong, China, 510150
Actively Recruiting
Research Team
F
Fang He, M.D
Q
Qingwen Nie, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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