Neuraxial Labor Analgesia and Offspring Neurodevelopment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorDong-Xin Wang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Neuraxial labor analgesia
Procedure/SurgeryEpidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
No neuraxial labor analgesia
Procedure/SurgeryNeuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
Treatment groups
4,645 Participants
are divided into 2 treatment groupsGroup A: Neuraxial analgesia exposure1 intervention
Group B: No neuraxial analgesia exposure1 intervention
Trial outcomes
Primary outcomes
1
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 ageSecondary outcomes
1
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 age2
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 childbirthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dong-Xin Wang
Lead sponsor
Peking University First Hospital
Sponsor institution
Shenzhen Maternity & Child Healthcare Hospital
Collaborator
Source ClinicalTrials.gov