Efficacy of Low Dose Acetylsalicylic Acid in Preventing Adverse Maternal and Perinatal Outcomes in SARS-CoV-2 Infected Pregnant Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Rate of composite adverse maternal and perinatal adverse outcomes including miscarriage, foetal death, preeclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age.
研究概览
简要总结
SARS-CoV-2 infection in pregnancy is associated with an increased risk of adverse maternal and perinatal outcomes. One explanation is that the infection might increase the existing pregnancy-associated prothrombotic status, leading to a higher risk of placental and vascular complications. Administration of low-dose acetylsalicylic acid (LDASA) has shown to improve maternal and perinatal outcomes in women at high-risk of endothelial and placental complications. However, there are no data on the effect of LDASA in preventing complications in SARS-CoV-2- infected pregnant women. To reduce SARS-CoV-2- related complications in a highly vulnerable group to the infection, we will carry out this randomized, double-blind, placebo-controlled multicentre trial in 400 SARS-CoV-2-infected pregnant women. The study main objective is to evaluate the efficacy and safety of LDASA administered up to 36 weeks of gestation in SARS-CoV-2-infected pregnant women in reducing the incidence of adverse maternal and perinatal outcomes. Pregnant women tested positive up to 32 weeks of gestation with a SARS-CoV-2 rapid antigen or PCR test and agreeing to participate, will be randomised 1:1 to receive daily LDASA (125 mg) or placebo up to 36 weeks of gestation and be followed-up until delivery.
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)
盲法说明
Study tablets will be identically packaged in small boxes. All study personnel, investigators and the participants will remain blinded throughout the trial.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women up to 32 weeks of gestational age
- •Aged 18 years or older*
- •Willing to deliver at the recruitment health facilities
- •In Mozambique, in case of age below 18 years, the participant will be asked for the assent and the informed consent will be given by the legal tutor in accordance with the national regulations.
排除标准
- •On regular ASA treatment for pre-eclampsia prevention
- •On long-term non-steroidal anti-inflammatory medication
- •Bleeding disorders, mainly haemophilia, hypoprothrombinaemia orVon Willebrand's disease
- •History of hypersensitivity to ASA or to any of the excipients of the investigational product.
- •History of peptic ulceration, including active, chronic or recurrent gastroduodenal ulcer; recurrent gastric discomfort History of gastric bleeding or perforation after treatment with aspirin or other non-steroidal anti-inflammatory drugs
- •Inability to cooperate with the requirements of the study
- •Severe COVID-19 disease (with any of the following: respiratory rate > 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).
- •Treatment resistant hyperemesis gravidarum
- •Hypersensitivity to nonsteroidal anti-inflammatory drugs or to tartrazine (cross-reaction) or to any of the excipients used in its composition.
- •Severe renal or hepatic insufficiency.
- •Nasal polyps associated with asthma that are induced or exacerbated by aspirin.
- •Severe COVID-19 disease (with any of the following: respiratory rate > 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).
- •Treatment resistant hyperemesis gravidarum
研究组 & 干预措施
LDASA (n=200)
干预措施: Low-dose acetylsalicylic acid (Drug)
Placebo (n=200)
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of composite adverse maternal and perinatal adverse outcomes including miscarriage, foetal death, preeclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age.
时间窗: up to 37 weeks
次要结局
- Incidence of preeclampsia(up to 37 weeks)
- Prevalence of small for gestational age(up to 37 weeks)
- Prevalence of embryo and foetal losses (miscarriages and stillbirths)(up to 37 weeks)
- Incidence of all-cause admissions(up to 37 weeks)
- Incidence of all-cause outpatient attendances(up to 37 weeks)
- Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy(up to 37 weeks)
- Incidence of COVID-19-related admissions(up to 37 weeks)
- Mean duration of symptoms-signs of COVID-19(up to 37 weeks)
- Frequency of congenital malformations(up to 37 weeks)
- Proportion of adverse perinatal outcome(up to 37 weeks)
- Neonatal morbidity(up to 37 weeks)
- Frequency and severity of adverse events(up to 37 weeks)
- Incidence of maternal thromboembolic complications and placental abruption(up to 37 weeks)
- Maternal mortality rate(up to 37 weeks)
- Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.(up to 37 weeks)
- Prevalence of preterm birth (<37 weeks of gestational age)(up to 37 weeks)
- Neonatal mortality rate(up to 37 weeks)