An observational study in Pregnant Women, Labor Pain and Analgesia, Epidural, sponsored by Dong-Xin Wang. Recruiting at 2 sites in China. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Dong-Xin Wang · Observational
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.
423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.
This study's planned enrollment of 4,645 is above the median of 132 across 62 observational studies indexed under Labor Pain.
Browse Labor Pain studies →Dong-Xin Wang is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Primiparae between 18 and 35 years of age with term single cephalic pregnancy who undergo regular prenatal examination in the study centers and are preparing to deliver vaginally.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For mothers who accept neuraxial labor analgesia, epidural analgesia or combined spinal-epidural analgesia will be provided according to routine practice of each study center.
Procedure: Neuraxial labor analgesia
For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.
Procedure: No neuraxial labor analgesia
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.
Prevalence of neurodevelopmental delay in offspring 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.
Time frame: At 24 months of age
Prevalence of neurodevelopmental delay in offspring 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.
Time frame: At 6 and 12 months of age
Prevalence of maternal depressive symptoms
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.
Time frame: At 42 days, 6 months, 12 months, and 24 months after childbirth
Plan to share: No
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