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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin discontinuation group | Experimental | initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, discontinuing aspirin at 28 weeks of gestation. |
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| Control group | Active Comparator | initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, receiving 1:1 randomized grouping at 24-27+6 weeks of gestation, continuing aspirin until 36 weeks of gestation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin discontinuation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of preterm preeclampsia | delivery with preeclampsia before 37 weeks of gestation | Within one week after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early-onset preeclampsia | delivery with preeclampsia before 34 weeks of gestation | Within one week after delivery |
| Incidence of term preeclampsia | delivery with preeclampsia after 37 weeks of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang He, M.D | Contact | +86 13724831279 | hefangjnu@126.com | |
| Qingwen Nie, Master | Contact | +86 15622149953 | qw0621n@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang He, M.D | The Third Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FANG HE | Recruiting | Guangzhou | Guangdong | 510150 | China |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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|
| aspirin continuation | Drug | 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. |
|
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| Within one week after delivery |
| Incidence of gestational hypertension | 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) | Within one week after delivery |
| Incidence of small for gestational age | birth weight below the 10th percentile | Within one week after delivery |