The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia

July 28, 2026 updated by: Zongxun Lin
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Traditional blind exploration of spinal canal puncture has many limitations, often forcing changes in anesthesia methods due to multiple puncture failures. However, the application of real-time ultrasound guidance technology in spinal canal puncture can completely solve this clinical difficulty. The ultrasound-guided real-time paramedian approach epidural puncture for labor analgesia is a new type of labor analgesia technology, and its specific operating standards and diagnostic and treatment routines have not yet been established, including the selection of puncture path, puncture needle model, distance between puncture hole and epidural injection point, drug type, dosage, solubility, volume and other parameters, all of which have great research space.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Class I or II;
  2. Single healthy pregnancy;
  3. Head showing first;
  4. 37 to 41 weeks;
  5. The labor process is active, and the cervix dilates<5cm;
  6. Require epidural labor analgesia;
  7. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

  1. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;
  2. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;
  3. Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;
  4. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.
  5. Patients with long-term use of opioids, steroids, and chronic pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group
Ultrasound real-time guidance combined with dural puncture epidural Can improve the clinical effect of labor analgesia.
Device: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia
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.
Active Comparator: Dural Puncture Epidural Group
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block.
Device: Dural Puncture Epidural Labor Analgesia
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite endpoint of labor analgesia outcome
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).

The primary outcome is a binary composite endpoint: "satisfactory" (Grades I-II) versus "unsatisfactory" (Grades III-IV). Grading followed a hierarchical rule (IV > III > II > I): if more than one grade applied, the highest (worst) was assigned.

Grade I (best): vaginal delivery (spontaneous or instrumental) with analgesic onset ≤ 20 min, mean VAS ≤ 40 mm, no catheter or protocol adjustment, and modified Bromage score < 2.

Grade II (good): vaginal delivery not meeting Grade I criteria but with onset ≤ 30 min, mean VAS ≤ 60 mm, and no Grade IV-listed complications.

Grade III (poor): cesarean delivery, or onset > 30 min, or mean VAS > 60 mm.

Grade IV (worst): serious analgesia-related complications (unintended dural puncture with the epidural needle, Bromage score ≥ 2, persistent neurological injury, local anesthetic toxicity, or severe hypotension requiring intervention).
From initiation of labor analgesia to delivery (assessed up to 24 hours).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to analgesia onset
Time Frame: Within 30 minutes after initial drug administration.
Time from initial drug administration to the first documented Visual Analogue Scale (VAS) score ≤ 30 mm. VAS scale: 0 = no pain, 100 mm = worst possible pain.
Within 30 minutes after initial drug administration.
Visual Analogue Scale (VAS) score
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Time-weighted mean pain VAS score from analgesia start to delivery, derived from area under the curve (AUC) calculation. VAS scale: 0 = no pain, 100 mm = worst possible pain.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Number of patient-controlled analgesia (PCA) demands
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Number of PCA bolus demands during labor analgesia.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Local anesthetic consumption
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Per-minute local anesthetic consumption during labor analgesia.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Sensory blockade level
Time Frame: During the labor analgesia period (assessed up to 24 hours).
Sensory blockade level assessed by loss of cold sensation using an alcohol swab, recorded at 30 min after the loading dose and at the highest level.
During the labor analgesia period (assessed up to 24 hours).
Incidence of asymmetric block
Time Frame: During the labor analgesia period (assessed up to 24 hours).
Defined as a ≥ 2-dermatome difference in sensory blockade level between the left and right sides.
During the labor analgesia period (assessed up to 24 hours).
Sensory blockade at the second sacral dermatome (S2)
Time Frame: During the labor analgesia period (assessed up to 24 hours).
S2 sensory blockade categorized as bilateral, unilateral, or none.
During the labor analgesia period (assessed up to 24 hours).
Number of Participants with Physician Interventions
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Physician interventions including analgesic regimen adjustments, epidural catheter repositioning, and re-puncture.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Modified Bromage score
Time Frame: During the labor analgesia period (assessed up to 24 hours).
Motor blockade assessed by the modified Bromage score: 0 = full flexion of knees and ankles, 1 = partial flexion of knees with full flexion of ankles, 2 = inability to flex knees with partial flexion of ankles, 3 = inability to flex knees and ankles.
During the labor analgesia period (assessed up to 24 hours).
Side effects of labor analgesia
Time Frame: From analgesia initiation until delivery and postpartum (assessed up to 72 hours).
Incidence of lower limb numbness (defined as loss of cold sensation by alcohol swab test), urinary retention (defined as inability to void spontaneously within 8 h postpartum requiring catheterization), nausea and vomiting, and postpartum headache.
From analgesia initiation until delivery and postpartum (assessed up to 72 hours).
Cesarean delivery rate and indications
Time Frame: At delivery.
Rate of cesarean delivery and indications for cesarean delivery (non-reassuring fetal heart rate, arrest of descent, maternal indications, other).
At delivery.
Mean uterine contraction frequency
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Time-weighted mean uterine contraction frequency, derived from area under the curve (AUC) calculation from analgesia to delivery. Unit of measure: contractions per 10 minutes
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Mean single uterine contraction duration
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Time-weighted mean single uterine contraction duration, derived from area under the curve (AUC) calculation from analgesia to delivery. Unit of measure: seconds.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Incidence of uterine hypertonia
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Defined as a single contraction lasting > 2 min.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Incidence of uterine tachysystole
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Defined as > 5 contractions per 10 min.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Duration of each stage of labor
Time Frame: From labor onset to delivery of the placenta (assessed up to 24 hours).
Duration of the first, second, third, and total stages of labor.
From labor onset to delivery of the placenta (assessed up to 24 hours).
Maternal body temperature
Time Frame: Pre-analgesia and at delivery.
Maternal body temperature before analgesia and at delivery.
Pre-analgesia and at delivery.
NICHD fetal heart rate tracing classification
Time Frame: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
NICHD (National Institute of Child Health and Human Development) Fetal Heart Tracing Classification: Category I (normal), Category II (indeterminate), Category III (abnormal). A higher category indicates a less reassuring fetal status.
From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
NICHD category progression rate
Time Frame: From baseline (pre-analgesia) through delivery (assessed up to 24 hours).
Proportion of parturients whose NICHD category worsened from baseline during labor analgesia.
From baseline (pre-analgesia) through delivery (assessed up to 24 hours).
Fetal heart rate
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Time-weighted mean fetal heart rate from analgesia to delivery, derived from area under the curve (AUC) calculation.
From initiation of labor analgesia to delivery (assessed up to 24 hours).
Fetal heart rate decelerations
Time Frame: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
Types of fetal heart rate decelerations (early, late, variable).
From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
Fetal heart rate variability
Time Frame: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
Fetal heart rate variability categorized as absent, minimal, moderate, or marked.
From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
Neonatal Apgar scores
Time Frame: At 1, 5, and 10 minutes after birth.
Apgar scores assessed at 1, 5, and 10 minutes after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better condition. The proportion of neonates with Apgar < 7 at 1 minute is also reported.
At 1, 5, and 10 minutes after birth.
Post-delivery hs-CRP level
Time Frame: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
Post-delivery hs-CRP level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: mg/L.
Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
Post-delivery IL-6 level
Time Frame: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
Post-delivery IL-6 level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: pg/mL.
Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
Post-delivery cortisol level
Time Frame: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
Post-delivery cortisol level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: nmol/L.
Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zongxun Lin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zongxun Lin, Master, Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ultrasound Real-time Guidance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings