NCT05990504

Brief Summary

Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal.Dural Puncture Epidural Technique improves Labor Analgesia Quality And Safety By Increasing Drug Permeation.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

April 21, 2023

Last Update Submit

December 10, 2025

Conditions

Labor Analgesia

Keywords

labor analgesiadelivery womanneonateEffectivenessSafety

Outcome Measures

Primary Outcomes (1)

  • The incidence of NICHD category elevation from baseline

    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 (e.g., III vs. I) indicates a less reassuring fetal status.

    From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).

Secondary Outcomes (25)

  • Distribution of NICHD categories (I, II, III)

    From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).

  • Fetal heart rate

    From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).

  • Duration of individual uterine contractions

    From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).

  • Incidence of hypertonus

    From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).

  • Incidence of tachysystole

    From the baseline assessment (pre-analgesia) through delivery(assessed up to 24 hours).

  • +20 more secondary outcomes

Study Arms (2)

Dural Puncture Epidural Group

EXPERIMENTAL

Dural Puncture Epidural is a new type of labor analgesia technology.

Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia

Epidural Group

ACTIVE COMPARATOR

Epidural is a traditional labor analgesia technique.

Device: ultrasound real-time guidance combined with Epidural Labor Anagesia

Interventions

ultrasound real-time guidance combined with Epidural Labor AnagesiaDEVICE

Epidural is a traditional labor analgesia technique.

Epidural Group
ultrasound real-time guidance combined with Dural Puncture Epidural Labor AnagesiaDEVICE

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.

Dural Puncture Epidural Group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) Class I or II;
  • Single healthy pregnancy;
  • Head showing first;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Study Officials

  • Zongxun Lin, Master

    Fujian Provincial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2023

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)