Neuraxial labour analgesia is associated with a reduced risk of maternal depression at 2 years after childbirth: A multicentre, prospective, longitudinal study.
Zhi-Hua Liu, Shu-Ting He, Chun-Mei Deng...
https://pubmed.ncbi.nlm.nih.gov/31356375Actively Recruiting
Age: 18Years - 35Years
FEMALE
ID04964206
Impact of Maternal Neuraxial Labor Analgesia on Offspring Neurodevelopment A Multicenter, Prospective, Longitudinal Cohort Study
Led by Dong-Xin Wang · Updated on 2025-07-31
5580
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
D
Dong-Xin Wang
Lead Sponsor
S
Shenzhen Maternity and Child Healthcare Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring how exposure to neuraxial labor analgesia, such as epidural or combined spinal-epidural analgesia given to mothers during labor, might affect the long-term brain development of their children. This study focuses on whether this pain relief method during childbirth is linked to developmental delays in children at 24 months of age. The study is observational and aims to clarify the potential benefits and risks of neuraxial analgesia by comparing neurodevelopment outcomes in children of mothers who did or did not receive this analgesia. Mothers who choose neuraxial labor analgesia will receive epidural or combined spinal-epidural analgesia following standard procedures at each study center. Those who do not opt for neuraxial analgesia will be given other pain relief medications as prescribed by their obstetricians. The study will monitor outcomes related to labor and delivery, including maternal fever, neonatal health at birth, and maternal depression, over the course of childbirth and up to two years after delivery. Participants will be followed from prenatal care through childbirth and up to 24 months after birth. Researchers will collect data on child developmental delays at 6, 12, and 24 months, maternal depression scores at multiple intervals, and clinical events such as neonatal infection and Apgar scores at birth. This comprehensive follow-up aims to understand the relationship between labor analgesia and child neurodevelopment over time, with safety and health evaluations conducted throughout the study period.
CONDITIONS
Brief Title
Neuraxial Labor Analgesia and Offspring Neurodevelopment
Who Can Participate
Age: 18Years - 35Years
FEMALE
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- History of psychiatric diseases diagnosed before or during pregnancy
- History of diseases involving the hypothalamic-pituitary-adrenal axis
- Contraindications to epidural analgesia including infectious diseases of the central nervous system, spinal or intra-spinal diseases, systemic infection, skin or soft tissue infection at epidural puncture site, or coagulopathy
- Contraindications to vaginal delivery
- Other reasons considered unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Observational Monitoring During Labor and Delivery
Duration - Up to the end of childbirth
Participants who undergo routine care for labor, including those who receive neuraxial labor analgesia or other analgesics, are observed for maternal and neonatal outcomes during labor and childbirth.
1 labor and delivery visit (in-person)
Neonatal Assessment
Duration - Within 3 days after birth
Neonatal health assessments including Apgar scores, infection monitoring, and histologic evaluation are conducted shortly after birth.
1 to 2 visits depending on neonatal assessments
Long-term Monitoring of Offspring Neurodevelopment
Duration - 24 months
Participants’ offspring are monitored for neurodevelopmental delay at multiple timepoints up to 24 months of age.
Visits at 6, 12, and 24 months of age
Maternal Postpartum Follow-up
Duration - 24 months
Mothers are assessed for depression scores at various points during the first 24 months after childbirth.
Visits at 42 days, 6, 12, and 24 months after childbirth
Trial Site Locations
Total: 2 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Shenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, China, 518100
Actively Recruiting
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Research Team
D
Dong-Xin Wang, MD,PHD
T
Ting Ding, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Advances in labor analgesia.
Cynthia A Wong
https://pubmed.ncbi.nlm.nih.gov/21072284Epidural analgesia, intrapartum hyperthermia, and neonatal brain injury: a systematic review and meta-analysis.
Sarah Morton, Justin Kua, Christopher J Mullington
https://pubmed.ncbi.nlm.nih.gov/33218673Neuraxial labor analgesia for vaginal delivery and its effects on childhood learning disabilities.
Randall P Flick, Kunmoo Lee, Ryan E Hofer...
https://pubmed.ncbi.nlm.nih.gov/20736436Association of Epidural Labor Analgesia With Offspring Risk of Autism Spectrum Disorders.
Elizabeth Wall-Wieler, Brian T Bateman, Ana Hanlon-Dearman...
https://pubmed.ncbi.nlm.nih.gov/33871547[Studies of the norm and psychometrical properties of the ages and stages questionnaires, third edition, with a Chinese national sample].
Mei Wei, Xiaoyan Bian, Jane Squires...
https://pubmed.ncbi.nlm.nih.gov/26887546