Comparison of Low Dose Aspirin vs Placebo in the Prevention of Recurrent Spontaneous Preterm Labou
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
- 主要终点
- Diagnostic Yield for Endometrial Pathology
研究概览
简要总结
Preterm birth-defined as delivery before 37 weeks of gestation-is a leading cause of neonatal morbidity and mortality worldwide, particularly in resource-limited settings. Women with a history of spontaneous preterm birth face a significantly higher risk of experiencing premature labor in subsequent pregnancies. Impaired uteroplacental blood flow, inflammation, and abnormal clot formation are key contributing factors to spontaneous preterm delivery.
Low-dose aspirin is an affordable, widely available medication that exerts anti-inflammatory and antithrombotic effects by inhibiting platelet aggregation and prostaglandin synthesis. This study aims to evaluate whether low-dose aspirin (75 mg daily), initiated between 8 and 16 weeks of gestation, can effectively reduce the incidence of recurrent spontaneous preterm labor in pregnant women with a prior history of premature delivery compared to a placebo. Participants will be monitored throughout their pregnancy up to 36 weeks or delivery to evaluate gestational age at birth and labor outcomes.
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
Participants are blinded to the treatment modality allotted to them using identical treatment and placebo preparations.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Singleton alive pregnancy.
- •History of spontaneous preterm birth (22 to 37 weeks of gestation).
- •Hemoglobin (Hb) > 10 g/dL.
- •Absence of fetal anomalies on ultrasound examination.
排除标准
- •Primigravida.
- •Multiple pregnancy.
- •Maternal age > 40 years.
- •Known history of allergy or hypersensitivity to aspirin.
- •Known maternal comorbidities including Pregnancy-Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, HELLP syndrome, thrombocytopenia, thrombocytopathy, or epilepsy.
- •Presence of a cervical cerclage prior to study enrollment.
研究组 & 干预措施
Group-II: Placebo Group
Participants receive a daily matching oral placebo starting from 8-16 weeks of gestation up to 36 weeks of gestation or until delivery, along with standard care (per-rectal progesterone and cervical cerclage if needed)
干预措施: Placebo (Other)
Group-I: Aspirin Group
Participants receive low-dose aspirin (75 mg once daily orally) starting from 8-16 weeks of gestation up to 36 weeks of gestation or until delivery, along with standard care (progesterone and cervical cerclage if indicated)
干预措施: Low-dose Aspirin (Drug)
结局指标
主要结局
Diagnostic Yield for Endometrial Pathology
时间窗: At the time of histopathological assessment (up to 7 days post-procedure)
Proportion of participants receiving a definitive histopathological diagnosis (e.g., normal/proliferative/secretory, endometrial hyperplasia, endometrial polyp, or malignancy) based on microscopic evaluation of the tissue specimen.
Incidence of Recurrent Spontaneous Preterm Labor
时间窗: From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation)
Proportion of participants who experience spontaneous onset of labor and delivery prior to completing 37 weeks (259 days) of gestation.
次要结局
未报告次要终点
研究者
Rida Tariq
Principle Investigator
University of Health Sciences Lahore