RecruitingNot Applicable

Neuraxial Labor Analgesia and Offspring Neurodevelopment

China4,645 participantsStarted 2022-10-14

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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;
. Other reasons that are considered unsuitable for study participation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of neurodevelopmental delay in offspring at 24 months of age

Timeframe: At 24 months of age

Trial details

NCT IDNCT04964206

SponsorDong-Xin Wang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Dong-Xin Wang, MD,PHD

86-13910731903 wangdongxin@hotmail.com

View on ClinicalTrials.gov More Pregnant Women trials