Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Birth weight
研究概览
简要总结
Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple pregnancies are considered a risk factor for all those adverse outcomes. The main objective of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an improvement of birthweight compared to placebo in twin pregnancies.
详细描述
Twin pregnancies represent approximately 3% of births and are associated with increased risks of complications such as preeclampsia, fetal growth restriction and preterm birth. All of these complications are commonly associated impaired placental function and low birth weight.
Most prophylactic measures tested over the years have failed to prevent these adverse outcomes in twin pregnancies. Since administration of low-dose of aspirin can improve placental function and all these adverse outcomes in high-risk pregnancies, mainly in women with prior adverse outcomes, we suggest that similar benefits could be seen in twins. We are expecting that the administration of low-dose of aspirin starting in the first-trimester in twin pregnancies could lead to an improvement of placental function, a reduction or these adverse perinatal outcomes and therefore to an improvement of birthweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age between 8 0/7 and 13 6/7 weeks
- •Twin pregnancy confirmed by ultrasound
排除标准
- •One or two negative heart beat
- •Previous hypertensive disorder of pregnancy
- •Pre-existing hypertension or diastolic blood pressure >90 mmHg at randomization
- •Pre-existing nephropathy
- •Pre-existing diabetes (type 1 or 2)
- •Anaphylactic allergy to lactose
- •Known coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C)
- •Use of heparin or other anticoagulants.
- •Contre-indications to aspirin
- •Discordance of crown-rump length greater than 20%.
- •Fetal anomalies (cystic hygroma, nuchal translucency > 95th percentile, anencephaly, omphalocele, etc.)
- •Previous or current gastric ulcer
研究组 & 干预措施
Experimental
Acetylsalicylic Acid 80mg administered daily at bedtime
干预措施: Acetylsalicylic Acid (Drug)
Control
Identical placebo administered daily at bedtime
干预措施: Placebo (Drug)
结局指标
主要结局
Birth weight
时间窗: At delivery
次要结局
- Very preterm birth(At delivery)
- Low birth weight(At delivery)
- Very low birth weight(At birth)
- Fetal growth restriction(16-18 and 22-24 weeks)
- Preterm birth(At delivery)
- Preeclampsia(At delivery)
- Early-onset preeclampsia(At delivery)
- UtA_PI(22-24 weeks)
- Aspirin resistance(16-18 and 22-24 weeks)
- Cervical length(22-24 weeks)