The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor An… (NCT06300151) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
China212 participantsStarted 2024-04-01
Plain-language summary
Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers.
Who can participate
Age range
20 Years – 45 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
. American Society of Anesthesiologists (ASA) Class I or II;
. Single healthy pregnancy;
. Head showing first;
. 37 to 41 weeks;
. The labor process is active, and the cervix dilates\<5cm;
. Require epidural labor analgesia;
. Volunteer to participate in this study and sign an informed consent form.
Exclusion criteria
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
1
Composite endpoint of labor analgesia outcome
Timeframe: From initiation of labor analgesia to delivery (assessed up to 24 hours).
. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;
. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;
. Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;
. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.
. Patients with long-term use of opioids, steroids, and chronic pain.