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

August 18, 2025 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.
Recruiting

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 (Estimated)

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.
80

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
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:

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: Triple

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
Analgesic effect（onset time）
Time Frame: 7 weeks
Analgesic effect of pregnant women（onset time）
7 weeks
Analgesic effect（block level）
Time Frame: 7 weeks
block level of pregnant women by Alcohol swab（temperature sensation：Pubic symphysis=T12，umbilical region=T10，hypochondrium=T8，xiphoid process=T6，Nipple connection=T4，subclavian=T2）
7 weeks
Analgesic effect（block effect）
Time Frame: 7 weeks
block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
7 weeks
Analgesic effect（Visual Analogue Scale）
Time Frame: 7 weeks
Analgesic effect of pregnant women by Visual Analogue Scale（scale title=Visual Analogue Scale，Total score=0-10,0=no pain,10=worst possible pain）
7 weeks
Uterine contraction indicators（Frequency）
Time Frame: 7 weeks
Assess uterine contractions（Frequency）
7 weeks
Uterine contraction indicators（duration）
Time Frame: 7 weeks
Assess uterine contractions（duration）
7 weeks
Uterine contraction indicators（Number of pregnant women with Tachysystole）
Time Frame: 7 weeks
Tachysystole=More than 5 Uterine contraction in 10 minutes
7 weeks
Uterine contraction indicators（Number of pregnant women with hypertonus）
Time Frame: 7 weeks
hypertonus=Each Uterine contraction lasts for more than 2 minutes
7 weeks
Fetal heart indicators（Fetal heart rate）
Time Frame: 7 weeks
Assess fetal heart（Fetal heart rate）
7 weeks
Fetal heart indicators（NICHD classification）
Time Frame: 7 weeks
Assess fetal heart（NICHD classification）
7 weeks
Fetal heart indicators（Fetal Heart Rate decelerations）
Time Frame: 7 weeks
Assess fetal heart（Fetal Heart Rate decelerations）
7 weeks
Fetal heart indicators（Fetal Heart Rate Variability）
Time Frame: 7 weeks
Assess fetal heart（Fetal Heart Rate Variability）
7 weeks
Apgar score
Time Frame: 7 weeks
Apgar score（scale title=Apgar score，Total score=0-10，0-3=severe asphyxia，4-7=mild asphyxia，8-10=normal）
7 weeks
modified bromage score
Time Frame: 7 weeks
modified bromage score（scale title=modified bromage score，Total score=0-3，0=no Motor nerve block; 1=unable to lift straight legs, but able to bend knees and move feet; 2=unable to lift straight legs or bend knees, but able to move feet; 3=unable to bend ankles, feet, or knees (completely blocked)）
7 weeks
Analgesic effect（number of Patient controlled analgesia）
Time Frame: 7 weeks
number of Patient controlled analgesia（Press the PCA button when the patient feels pain）
7 weeks
Analgesic effect（time of Patient controlled analgesia）
Time Frame: 7 weeks
time of Patient controlled analgesia（Press the PCA button when the patient feels pain）
7 weeks
Sacral sensory block of pregnant women
Time Frame: 7 weeks
Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
7 weeks

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
Operation evaluation（Time）
Time Frame: 7 weeks
Assessment of puncture condition（Time）
7 weeks
Operation evaluation（number of times）
Time Frame: 7 weeks
Assessment of puncture condition（number of times）
7 weeks
Operation evaluation（side effects and Complications）
Time Frame: 7 weeks
Assessment of puncture condition（side effects and Complications）
7 weeks
Delivery mode
Time Frame: 7 weeks
natural labor/cesarean section/instrument
7 weeks
Concentration of Interleukin 6
Time Frame: 7 weeks
Pregnant women's venous blood Interleukin 6
7 weeks
Concentration of hypersensitive C-reactive protein
Time Frame: 7 weeks
Pregnant women's venous blood hypersensitive C-reactive protein
7 weeks
Concentration of cortisol
Time Frame: 7 weeks
Pregnant women's venous blood cortisol
7 weeks
Maternal rehabilitation indicators（Postpartum hospital stay）
Time Frame: 7 weeks
Postpartum hospitalization days
7 weeks
Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）
Time Frame: 7 weeks
Edinburgh Postnatal Depression Scale（scale title=Edinburgh Postnatal Depression Scale，Total score=0-30，≥13=Postpartum depression）
7 weeks
Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））
Time Frame: 7 weeks
Postoperative Recovery Quality Scale（QOR-40）（scale title=Postoperative Recovery Quality Scale（QOR-40），Total score=0-200，The higher the score the better the recovery）
7 weeks
Number of pregnant women with adjust the treatment plan and adjustment method
Time Frame: 7 weeks
adjustment method include Adjust the Epidural catheter or Adjusting drug dosage
7 weeks
Drug consumption
Time Frame: 7 weeks
Drug consumption
7 weeks
Effect of stages of labor（time）
Time Frame: 7 weeks
Effect of stages of labor（time）
7 weeks
body temperature changes
Time Frame: 7 weeks
body temperature changes
7 weeks
Number of pregnant women with Infection during labor
Time Frame: 7 weeks
whether Infection during labor of pregnant women
7 weeks
Side effects and complications of labor analgesia
Time Frame: 7 weeks
Side effects and complications of labor analgesia
7 weeks
Self-Rating Anxiety Scale
Time Frame: 7 weeks
Self-Rating Anxiety Scale（scale title=Self-Rating Anxiety Scale，Total score=0-80，≥50=Anxiety）
7 weeks
Delivery fear score（numerical rating scale）
Time Frame: 7 weeks
Delivery fear score by numerical rating scale（scale title=numerical rating scale，Total score=0-10，≥6=Delivery fear）
7 weeks
Delivery satisfaction survey
Time Frame: 7 weeks
Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)
7 weeks
The reasons and number of pregnant women with conversion of natural labor to Caesarean section
Time Frame: 7 weeks
Reasons and number for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)
7 weeks

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 (Estimated)

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 1, 2025

Study Completion (Estimated)

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.
August 22, 2025

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.
August 18, 2025

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, 2025

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.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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