Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT06300151
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2024-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic effect（onset time）', 'timeFrame': '7 weeks', 'description': 'Analgesic effect of pregnant women（onset time）'}, {'measure': 'Analgesic effect（block level）', 'timeFrame': '7 weeks', 'description': '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）'}, {'measure': 'Analgesic effect（block effect）', 'timeFrame': '7 weeks', 'description': 'block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）'}, {'measure': 'Analgesic effect（Visual Analogue Scale）', 'timeFrame': '7 weeks', 'description': '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）'}, {'measure': 'Analgesic effect（number of Patient controlled analgesia）', 'timeFrame': '7 weeks', 'description': 'number of Patient controlled analgesia（Press the PCA button when the patient feels pain）'}, {'measure': 'Analgesic effect（time of Patient controlled analgesia）', 'timeFrame': '7 weeks', 'description': 'time of Patient controlled analgesia（Press the PCA button when the patient feels pain）'}, {'measure': 'Uterine contraction indicators（Frequency）', 'timeFrame': '7 weeks', 'description': 'Assess uterine contractions（Frequency）'}, {'measure': 'Uterine contraction indicators（duration）', 'timeFrame': '7 weeks', 'description': 'Assess uterine contractions（duration）'}, {'measure': 'Uterine contraction indicators（Number of pregnant women with Tachysystole）', 'timeFrame': '7 weeks', 'description': 'Tachysystole=More than 5 Uterine contraction in 10 minutes'}, {'measure': 'Uterine contraction indicators（Number of pregnant women with hypertonus）', 'timeFrame': '7 weeks', 'description': 'hypertonus=Each Uterine contraction lasts for more than 2 minutes'}, {'measure': 'Fetal heart indicators（Fetal heart rate）', 'timeFrame': '7 weeks', 'description': 'Assess fetal heart（Fetal heart rate）'}, {'measure': 'Fetal heart indicators（NICHD classification）', 'timeFrame': '7 weeks', 'description': 'Assess fetal heart（NICHD classification）'}, {'measure': 'Fetal heart indicators（Fetal Heart Rate decelerations）', 'timeFrame': '7 weeks', 'description': 'Assess fetal heart（Fetal Heart Rate decelerations）'}, {'measure': 'Fetal heart indicators（Fetal Heart Rate Variability）', 'timeFrame': '7 weeks', 'description': 'Assess fetal heart（Fetal Heart Rate Variability）'}, {'measure': 'Apgar score', 'timeFrame': '7 weeks', 'description': 'Apgar score（scale title=Apgar score，Total score=0-10，0-3=severe asphyxia，4-7=mild asphyxia，8-10=normal）'}, {'measure': 'Sacral sensory block of pregnant women', 'timeFrame': '7 weeks', 'description': 'Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）'}, {'measure': 'modified bromage score', 'timeFrame': '7 weeks', 'description': '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)）'}], 'secondaryOutcomes': [{'measure': 'Operation evaluation（Time）', 'timeFrame': '7 weeks', 'description': 'Assessment of puncture condition（Time）'}, {'measure': 'Operation evaluation（number of times）', 'timeFrame': '7 weeks', 'description': 'Assessment of puncture condition（number of times）'}, {'measure': 'Operation evaluation（side effects and Complications）', 'timeFrame': '7 weeks', 'description': 'Assessment of puncture condition（side effects and Complications）'}, {'measure': 'Delivery mode', 'timeFrame': '7 weeks', 'description': 'natural labor/cesarean section/instrument'}, {'measure': 'Concentration of Interleukin 6', 'timeFrame': '7 weeks', 'description': "Pregnant women's venous blood Interleukin 6"}, {'measure': 'Concentration of hypersensitive C-reactive protein', 'timeFrame': '7 weeks', 'description': "Pregnant women's venous blood hypersensitive C-reactive protein"}, {'measure': 'Concentration of cortisol', 'timeFrame': '7 weeks', 'description': "Pregnant women's venous blood cortisol"}, {'measure': 'Maternal rehabilitation indicators（Postpartum hospital stay）', 'timeFrame': '7 weeks', 'description': 'Postpartum hospitalization days'}, {'measure': 'Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）', 'timeFrame': '7 weeks', 'description': 'Edinburgh Postnatal Depression Scale（scale title=Edinburgh Postnatal Depression Scale，Total score=0-30，≥13=Postpartum depression）'}, {'measure': 'Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））', 'timeFrame': '7 weeks', 'description': '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）'}, {'measure': 'Number of pregnant women with adjust the treatment plan and adjustment method', 'timeFrame': '7 weeks', 'description': 'adjustment method include Adjust the Epidural catheter or Adjusting drug dosage'}, {'measure': 'Drug consumption', 'timeFrame': '7 weeks', 'description': 'Drug consumption'}, {'measure': 'Effect of stages of labor（time）', 'timeFrame': '7 weeks', 'description': 'Effect of stages of labor（time）'}, {'measure': 'body temperature changes', 'timeFrame': '7 weeks', 'description': 'body temperature changes'}, {'measure': 'Number of pregnant women with Infection during labor', 'timeFrame': '7 weeks', 'description': 'whether Infection during labor of pregnant women'}, {'measure': 'Side effects and complications of labor analgesia', 'timeFrame': '7 weeks', 'description': 'Side effects and complications of labor analgesia'}, {'measure': 'The reasons and number of pregnant women with conversion of natural labor to Caesarean section', 'timeFrame': '7 weeks', 'description': 'Reasons and number for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)'}, {'measure': 'Self-Rating Anxiety Scale', 'timeFrame': '7 weeks', 'description': 'Self-Rating Anxiety Scale（scale title=Self-Rating Anxiety Scale，Total score=0-80，≥50=Anxiety）'}, {'measure': 'Delivery fear score（numerical rating scale）', 'timeFrame': '7 weeks', 'description': 'Delivery fear score by numerical rating scale（scale title=numerical rating scale，Total score=0-10，≥6=Delivery fear）'}, {'measure': 'Delivery satisfaction survey', 'timeFrame': '7 weeks', 'description': 'Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound Real-time Guidance', 'labor analgesia', 'delivery woman', 'neonate', 'Effectiveness', 'Safety'], 'conditions': ['Labor Analgesia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) Class I or II;\n2. Single healthy pregnancy;\n3. Head showing first;\n4. 37 to 41 weeks;\n5. The labor process is active, and the cervix dilates\\<5cm;\n6. Require epidural labor analgesia;\n7. Volunteer to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;\n2. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;\n3. Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;\n4. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.\n5. Patients with long-term use of opioids, steroids, and chronic pain.'}, 'identificationModule': {'nctId': 'NCT06300151', 'briefTitle': 'The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia', 'orgStudyIdInfo': {'id': 'Ultrasound Real-time Guidance'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group', 'description': 'Ultrasound real-time guidance combined with dural puncture epidural Can improve the clinical effect of labor analgesia.', 'interventionNames': ['Device: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dural Puncture Epidural Group', 'description': '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.', 'interventionNames': ['Device: Dural Puncture Epidural Labor Analgesia']}], 'interventions': [{'name': 'Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group']}, {'name': 'Dural Puncture Epidural Labor Analgesia', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Dural Puncture Epidural Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zongxun Lin, Master', 'role': 'CONTACT', 'email': '13763820916@189.cn', 'phone': '+8613763820916'}], 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Zongxun Lin, Master', 'role': 'CONTACT', 'email': '13763820916@189.cn', 'phone': '+8613763820916'}], 'overallOfficials': [{'name': 'Zongxun Lin, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Provincial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zongxun Lin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zongxun Lin', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}