protocolSection identificationModule nctId: NCT06300151, orgStudyIdInfo id: Ultrasound Real-time Guidance, briefTitle: The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Zongxun Lin, class: OTHER, 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., conditionsModule conditions: Labor Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia, interventions name: Dural Puncture Epidural Labor Analgesia, outcomesModule primaryOutcomes measure: Analgesic effect（onset time）, primaryOutcomes measure: Analgesic effect（block level）, primaryOutcomes measure: Analgesic effect（block effect）, primaryOutcomes measure: Analgesic effect（Visual Analogue Scale）, primaryOutcomes measure: Analgesic effect（number of Patient controlled analgesia）, primaryOutcomes measure: Analgesic effect（time of Patient controlled analgesia）, primaryOutcomes measure: Uterine contraction indicators（Frequency）, primaryOutcomes measure: Uterine contraction indicators（duration）, primaryOutcomes measure: Uterine contraction indicators（Number of pregnant women with Tachysystole）, primaryOutcomes measure: Uterine contraction indicators（Number of pregnant women with hypertonus）, primaryOutcomes measure: Fetal heart indicators（Fetal heart rate）, primaryOutcomes measure: Fetal heart indicators（NICHD classification）, primaryOutcomes measure: Fetal heart indicators（Fetal Heart Rate decelerations）, primaryOutcomes measure: Fetal heart indicators（Fetal Heart Rate Variability）, primaryOutcomes measure: Apgar score, primaryOutcomes measure: Sacral sensory block of pregnant women, primaryOutcomes measure: modified bromage score, secondaryOutcomes measure: Operation evaluation（Time）, secondaryOutcomes measure: Operation evaluation（number of times）, secondaryOutcomes measure: Operation evaluation（side effects and Complications）, secondaryOutcomes measure: Delivery mode, secondaryOutcomes measure: Concentration of Interleukin 6, secondaryOutcomes measure: Concentration of hypersensitive C-reactive protein, secondaryOutcomes measure: Concentration of cortisol, secondaryOutcomes measure: Maternal rehabilitation indicators（Postpartum hospital stay）, secondaryOutcomes measure: Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）, secondaryOutcomes measure: Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））, secondaryOutcomes measure: Number of pregnant women with adjust the treatment plan and adjustment method, secondaryOutcomes measure: Drug consumption, secondaryOutcomes measure: Effect of stages of labor（time）, secondaryOutcomes measure: body temperature changes, secondaryOutcomes measure: Number of pregnant women with Infection during labor, secondaryOutcomes measure: Side effects and complications of labor analgesia, secondaryOutcomes measure: The reasons and number of pregnant women with conversion of natural labor to Caesarean section, secondaryOutcomes measure: Self-Rating Anxiety Scale, secondaryOutcomes measure: Delivery fear score（numerical rating scale）, secondaryOutcomes measure: Delivery satisfaction survey, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fujian Provincial Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350001, country: China, contacts name: Zongxun Lin, Master, role: CONTACT, phone: +8613763820916, email: 13763820916@189.cn, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False