Clinical Randomized Controlled Trial of Aspirin in the Treatment of Pregnant Women With Adenomyosis on Reducing Preterm Delivery
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 550
- 主要终点
- preterm delivery
研究概览
简要总结
Objective: This study intends to carry out a randomized double-blind clinical trial study of aspirin in the treatment of pregnancy with adenomyosis to reduce the incidence of preterm delivery, and provide a new therapeutic target for the prevention and treatment of premature birth and adverse pregnancy outcomes, and fill in the blank of effective prevention of premature delivery in pregnancy with adenomyosis at home and abroad Application value and social and economic benefits of the bed.
Methods: a randomized double-blind clinical trial was used in this study. In Shanghai first maternal and child health care hospital, the pregnant women who meet the requirements of the group will be given full informed consent. By using a random, double-blind research method, 1-550 digital computers are randomly divided into two groups, with two groups of digital coding placebo and aspirin. From 12 weeks of gestation, 100 mg of placebo or low-dose aspirin was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.
Observe the outcome ① Main outcome measures: preterm delivery: delivery less than 37 weeks gestational weeks, premature delivery. The specific classification includes: A. extremely premature delivery, gestational age 28-32 weeks; B. early preterm birth, delivery gestational weeks 32-34 gestational weeks; C. late preterm birth, 34-36 gestational weeks.
② Secondary outcome measures: abortion, gestational diabetes mellitus, gestational hypertension, placental disorders, SGA / FGR, premature rupture of membranes, postpartum hemorrhage, mode of delivery, etc.
The follow-up contents were as follows
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Routine prenatal examination, blood pressure, fetal size, vaginal bleeding, etc.
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Coagulation factor index: prothrombin time Pt, activated partial thrombin time APTT, thrombin time TT, fibrinogen FIB, D-dimer
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Immune related indexes: antiphospholipid antibody, CA125 ④ Inflammatory index: routine blood test + CRP
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Detection of cervical length by B-ultrasound ⑥ Pregnancy complications: gestational diabetes mellitus, gestational hypertension and placental disorders ⑦ Birth outcome: gestational weeks, birth weight, FGR, premature delivery, mode of delivery, NICU rate, etc.
详细描述
Research background:
Adenomyosis (AD) is a benign uterine disease with endometrial glands and stroma invading into the myometrium, accompanied by hyperplasia and hypertrophy of uterine smooth muscle cells, which leads to abnormal uterine structure and function. In non pregnancy period, the main manifestations are diffuse enlargement of uterus, dysmenorrhea, menorrhagia, menorrhagia, which can lead to infertility. In recent years, with the delay of childbearing age, the incidence of adenomyosis in pregnancy is increasing gradually. The incidence of adenomyosis in the general population reached 20.9%, while the incidence of adenomyosis was higher in recurrent abortion and assisted reproduction, reaching 38.2% and 34.7% respectively. Studies have shown that adenomyosis is associated with early preterm delivery, late preterm delivery, low birth weight infants, very low birth weight infants, and small for gestational age infants. Patients with adenomyosis are prone to hypertensive disorder complicating pregnancy, intrauterine infection, abnormal placenta, and increased cesarean section, postpartum hemorrhage and abnormal fetal position.
Aspirin is widely used in the treatment of immune system diseases and the prevention of cerebrovascular diseases because of its anti-inflammatory and anti platelet aggregation effects. Aspirin is more and more widely used in obstetrics and Gynecology, such as recurrent abortion caused by antiphospholipid antibody syndrome, recurrent abortion related to abnormal uterine artery blood flow and unexplained recurrent abortion. Since 1980, aspirin has been widely recommended for the prevention of pregnancy with high risk factors of preeclampsia and intrauterine growth restriction, and it has been confirmed that aspirin is effective in the prevention of pregnancy It is safe in clinical application. The inflammatory environment of adenomyosis is closely related to the initiation of preterm delivery, but whether aspirin can benefit pregnant women with adenomyosis is still lacking.
Research plan
- Study population Inclusive criteria: ① Singleton; ② in line with the diagnosis of adenomyosis in pregnancy; ③ no history of chronic diseases and definite diagnosis of endocrine diseases, including diabetes, hypertension, obesity, antiphospholipid syndrome; ④ informed consent and voluntary participation in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •① Singleton; ② in line with the diagnosis of adenomyosis in pregnancy; ③ no history of chronic diseases and definite diagnosis of endocrine diseases, including diabetes, hypertension, obesity, antiphospholipid syndrome; ④ informed consent and voluntary participation in this study.
排除标准
- •① twins / multiple births; ② induced labor for medical reasons; ③ allergic to aspirin or other salicylates, tetracycline drugs or any other components of drugs; ④ patients with mental disorders; ⑤ transferred to hospital.
研究组 & 干预措施
Aspirin group
100 mg of low-dose aspirin was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.
干预措施: Aspirin/placebo (Drug)
placebo group
100 mg of placebo was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.
干预措施: Aspirin/placebo (Drug)
结局指标
主要结局
preterm delivery
时间窗: Gestation 12-36 weeks
delivery less than 37 weeks gestational weeks, premature delivery. The specific classification includes: A. extremely premature delivery, gestational age 28-32 weeks; B. early preterm birth, delivery gestational weeks 32-34 gestational weeks; C. late preterm birth, 34-36 gestational weeks.
次要结局
- Other complications(Gestation 12-36 weeks)