Compare spinal-epidural versus general anesthesia for babies after cesarean delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, single-blind randomized trial enrolling 144 pregnant women undergoing elective cesarean delivery. Participants are randomized to receive either combined spinal-epidural anesthesia or general anesthesia. Neonatal hearing is screened with transient evoked otoacoustic emissions (TEOAE) and followed up at 3-6 months if initial screening is failed; additional data include maternal hemodynamics, time from anesthesia start to delivery, Apgar scores, and maternal pain scores. Outcome assessors are blinded to group assignment to reduce bias. The study uses sealed allocation and independent statistical planning to ensure proper randomization.

Why it matters

Who can join: the full rules

Inclusion Criteria:(a) Singleton pregnancy with gestational age 37-42 weeks; (b) Maternal age 18-35 years; (c) American Society of Anesthesiologists (ASA) physical status II; (d) Scheduled for elective cesarean delivery based on clinical indications; (e) Written informed consent obtained from the parturient and her family.

Exclusion Criteria:

1. Refusal to participate;
2. Contraindications to neuraxial anesthesia;
3. Severe comorbidities, including hypertensive disorders of pregnancy, cardiovascular disease, hepatic or renal dysfunction, or coagulation abnormalities;
4. History of psychiatric disorders, severe anxiety or depression, or chronic preoperative use of sedative or analgesic medications;
5. Neonatal hyperbilirubinemia or birth weight \<2,500 g;
6. Anticipated intraoperative conditions that would prevent completion of the study per the prespecified protocol.

Where it's running

• The Second Affiliated Hospital of Wenzhou Medical University
  Wenzhou, China Recruiting

Study contacts

• Study coordinator: Baiping Mao, PhD
• Email: baipingmaowmu@163.com
• Phone: +860577-85676879

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.