Perinatal Haemorrhage, Preeclampsia
Conditions
Keywords
low dose aspirin, prevention, preeclampsia, pregnancy outcomes, randomized controlled trial, aspirin discontinuation
Brief summary
Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.
Detailed description
This study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm PE is not inferior to 36 weeks of gestation. We will include pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors. During 12-16 weeks of gestation, the mean arterial pressure (MAP) and placental growth factor (PlGF) are measured, then initiating aspirin 100mg qn. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sFlt-1 and PlGF were detected at the same time. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. The incidence of preterm PE in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.
Interventions
Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, discontinuing aspirin at 28 weeks of gestation according to randomization at 24-27+6 weeks of gestation.
Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, continuing aspirin until 36 weeks of gestation according to randomization at 24-27+6 weeks of gestation.
Sponsors
FANG HE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors are included. Initiating aspirin 100mg qn during 12-16 weeks of gestation. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. At \<16 weeks of gestation, normal NT scan 2. At least 1 high risk factor or at least 2 moderate risk factors 3. Intend to receive prenatal examination and deliver in this institution 4. Signed a written informed consent for participation in the study
Exclusion criteria
1. Aspirin initiated after 16 week 2. Intolerant or allergic to aspirin 3. Aspirin adherence was \<80% 4. Miscarriage or termination of pregnancy before randomization 5. drop out (do not return to the hospital for delivery). 6. Lost to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of preterm preeclampsia | Within one week after delivery | delivery with preeclampsia before 37 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of early-onset preeclampsia | Within one week after delivery | delivery with preeclampsia before 34 weeks of gestation |
| Incidence of term preeclampsia | Within one week after delivery | delivery with preeclampsia after 37 weeks of gestation |
| Incidence of gestational hypertension | Within one week after delivery | new onset of high blood pressure after 20 weeks of gestation (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg) |
| Incidence of small for gestational age | Within one week after delivery | birth weight below the 10th percentile |
Countries
China
Contacts
Primary ContactFang He, M.D
Backup ContactQingwen Nie, Master
Outcome results
None listed