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.
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.
Study Type
OBSERVATIONAL
Enrollment
5,580
Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGShenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, China
RECRUITINGIncidence of developmental delay in offspring 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.
Time frame: At 24 months of age
Incidence of developmental delay in offspring at 6 and 12 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.
Time frame: At 6 and 12 months of age
Maternal intrapartum fever
Defined as the highest maternal temperature ≥38.0℃ during any stage of labor.
Time frame: Up to the end of childbirth (stage 3)
Neonatal Apgar score <8 at 1 and 5 minutes after delivery
Neonatal Apgar score is assessed and recorded by gynecologists or midwives at 1 and 5 minutes after delivery.
Time frame: At 1 and 5 minutes after delivery
Histologic chorioamnionitis
According to pathological examination of placenta
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Time frame: Up to hospital discharge
Neonatal infection
Neonatal infection is defined by the occurrence of 1 or more of the following: neonatal sepsis, neonatal uncharacterized infection, neonatal pneumonia, or neonatal necrotizing enterocolitis diagnosed according to the Chinese Classification of Disease and Codes (Version 2.0, International Statistical Classification of Diseases and Related Health Problems, Tenth Revision \[ICD-10\]) established by the Chinese government.
Time frame: Within 3 days after birth
Depression score of mothers
Maternal depression is assessed with the Edinburgh Postnatal Depression Scale. A score of 10 or higher is defined the presence of depressive symptoms.
Time frame: At 42 days, 6 months, 12 months, and 24 months after childbirth