Analgesia, Epidural, Infants, Labor Pain, Neurodevelopmental Disorders, Pregnant Women
Conditions
Keywords
Pregnant women, Labor pain, Neuraxial labour analgesia, Infants, Neurodevelopmental disorders
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURENeuraxial labor analgesia
Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
PROCEDURENo neuraxial labor analgesia
Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
Sponsors
Dong-Xin Wang
Shenzhen Maternity & Child Healthcare Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Primiparae between 18 and 35 years of age with term single cephalic pregnancy; 2. Undergo regular prenatal examination in the study centers; 3. Preparing to deliver vaginally.
Exclusion criteria
1. History of psychiatric diseases (indicate those that are diagnosed before or during pregnancy by psychiatrists); 2. History of diseases involving the hypothalamic-pituitary-adrenal axis; 3. 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. 4. Presence of contraindications to vaginal delivery; 5. Other reasons that are considered unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of neurodevelopmental delay in offspring at 24 months of age | At 24 months of age | Neurodevelopment will be assessed using the Ages \& Stages Questionnaires® in Chinese, 3rd edition (ASQ®-3 Chinese; suitable for 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 neurodevelopmental delay. A score below the threshold in any of the 5 domains indicates suspected neurodevelopmental delay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of neurodevelopmental delay in offspring at 6 and 12 months of age | At 6 and 12 months of age | Neurodevelopment will be assessed using the Ages \& Stages Questionnaires® in Chinese, 3rd edition (ASQ®-3 Chinese; suitable for 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. |
| Prevalence of maternal depressive symptoms | At 42 days, 6 months, 12 months, and 24 months after childbirth | Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; scores range from 0 to 30, with higher scores inddicating more severe depressive symptoms). A EPDS score of 10 or higher is defined the presence of depressive symptoms. |
Countries
China
Contacts
CONTACTDong-Xin Wang, MD,PHD
CONTACTTing Ding, MD
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD,PHD
Peking University First Hospital
Outcome results
None listed