Actively Recruiting
The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Led by Zongxun Lin · Updated on 2025-08-22
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying labor analgesia in women using ultrasound real-time guidance technology to improve the accuracy, success rate, and safety of spinal block procedures compared to traditional blind exploration methods. This study focuses on the benefits of Doppler ultrasound and real-time ultrasound guidance, which have been limited in clinical use due to equipment demands, complex operation, and a steep learning curve. The goal is to develop a comprehensive treatment plan to enhance mothers' delivery experience. The trial compares two methods: ultrasound real-time guidance combined with dural puncture epidural labor analgesia and dural puncture epidural labor analgesia alone. The dural puncture epidural method involves completing an epidural puncture, puncturing the dura mater with a subarachnoid needle without injecting drugs into the subarachnoid space, and then using an epidural catheter for drug administration. The ultrasound guidance aims to improve the precision and safety of this procedure. Participants will be monitored for various outcomes over seven weeks, including analgesic effects such as onset time, block level, and patient-controlled analgesia use. Researchers will also assess uterine contraction indicators, fetal heart measures, Apgar scores, and maternal sensory and motor block levels. Secondary outcomes include operation evaluation, side effects, delivery mode, inflammatory markers, postpartum recovery, drug consumption, labor stages, maternal anxiety, and delivery satisfaction. Safety and treatment adjustments will also be tracked throughout the study period.
CONDITIONS
Brief Title
The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists (ASA) Class I or II
- Single healthy pregnancy
- Baby's head is presenting first
- Pregnancy between 37 and 41 weeks
- Active labor with cervix dilation less than 5 cm
- Requires epidural labor analgesia
- Voluntary participation with signed informed consent
You will not qualify if you...
- Pregnancy diseases such as hypertension, preeclampsia, or diabetes
- Contraindications to intraspinal analgesia including central nervous system diseases, infection or septicemia at puncture site, or coagulation dysfunction
- Known fetal malformation or increased risk of cesarean section, such as history of uterine rupture
- History of mental illness, hysteria, epilepsy, or inability to cooperate
- Long-term use of opioids, steroids, or chronic pain conditions
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During active labor until delivery
Participants receive either ultrasound real-time guidance combined with dural puncture epidural labor analgesia or dural puncture epidural labor analgesia to manage labor pain.
1 visit at labor for analgesia procedure
Duration - Up to 7 weeks after delivery
Participants are monitored for effectiveness and safety outcomes related to labor analgesia, including pain relief, uterine contractions, fetal heart indicators, and maternal recovery.
Multiple follow-up visits during 7 weeks postpartum
Trial Site Locations
Total: 1 location
1
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Z
Zongxun Lin, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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