Impact of Maternal Neuraxial Labor Analgesia on Offspring Neurodevelopment. A Multicenter, Prospective, Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,645
- 试验地点
- 2
- 主要终点
- Incidence of developmental delay in offspring at 24 months of age
研究概览
简要总结
How perinatal factors affect the long-term development of children has always been an issue of much concern. This study is designed to explore the potential impact of maternal neuraxial labor analgesia exposure on offspring neurodevelopment.
详细描述
Neuraxial labor analgesia, including epidural analgesia and combined spinal-epidural analgesia, is a well-established technique to alleviate labor pain. It can help to reduce the maternal stress response during labor and might be associated with a lower risk of maternal postpartum depression; which may be beneficial to the long-term neurodevelopment in offspring.
On the other hand, neuraxial labor analgesia is associated with increased risks of intrapartum maternal fever and instrumental delivery, which may produce potentially harmful effects. In addition, it has been reported that the anesthetic exposure during neuraxial analgesia may lead to fetal-neonatal depression and even neurotoxic effects of less mature neonatal brain. Taking all these into account, the potential long-term effects of neuraxial analgesia on offspring neurodevelopment is still controversial and deserves further study.
The objective of study is to investigate if there is any association between maternal neuraxial analgesia exposure during labor and risk of offspring neurodevelopment delay at age 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparae between 18 and 35 years of age with term single cephalic pregnancy;
- •Undergo regular prenatal examination in the study centers;
- •Preparing to deliver vaginally.
排除标准
- •History of psychiatric diseases (indicate those that are diagnosed before or during pregnancy by psychiatrists);
- •History of diseases involving the hypothalamic-pituitary-adrenal axis;
- •Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
- •Presence of contraindications to vaginal delivery;
- •Other reasons that are considered unsuitable for study participation.
结局指标
主要结局
Incidence of developmental delay in offspring at 24 months of age
时间窗: At 24 months of age
The Ages \& Stages Questionnaires® in Chinese, 3rd edition (ASQ®-3 Chinese) will be used to detect developmental delays among children from 1 month to 60 months of age. The ASQ®-3 Chinese contains 30 items representing five developmental domains: communication, gross motor, fine motor, problem solving, and personal-social behavior. For each domain, a score that is more than 2 standard deviations below the mean indicates suspected developmental delay. A score below the threshold in any of the 5 domains indicates suspected developmental delay.
次要结局
- Incidence of developmental delay in offspring at 6 and 12 months of age(At 6 and 12 months of age)
- Maternal intrapartum fever(Up to the end of childbirth (stage 3))
- Neonatal Apgar score <8 at 1 and 5 minutes after delivery(At 1 and 5 minutes after delivery)
- Histologic chorioamnionitis(Up to hospital discharge)
- Neonatal infection(Within 3 days after birth)
- Depression score of mothers(At 42 days, 6 months, 12 months, and 24 months after childbirth)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital