NCT00647725

Brief Summary

Painless labor is an essential part in woman's health care. Labor analgesia in the active phrase is in popular use currently. However, parturients are still haunted by the labor delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore, we hypothesized that labor analgesia in the latent phrase of the first delivery stage would provide superior health care for laboring women. In addition, such analgesia technique would not prolong the time of uterine dilation and labor delivering.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 1, 2003

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

4.9 years

First QC Date

March 28, 2008

Last Update Submit

September 30, 2009

Conditions

Labor Pain

Keywords

Epidural analgesiaLatent analgesiaActive analgesiaLabor delivery

Outcome Measures

Primary Outcomes (1)

  • Rate of Cesarean delivery

    The time of the end of the labor

Secondary Outcomes (11)

  • Time of latent phrase

    From the beginning of regular contraction of uterus to the diameter of cervix to 4cm

  • Time of labor

    From the beginning of regular contraction of uterus to the end of the labor

  • Overall feeling of satisfaction of analgesia

    From the beginning of regular contraction of uterus to the end of the labor

  • Side effects

    From the beginning of regular contraction of uterus to the end of the labor

  • VAS pain intensity

    From the intinition of analgesia to the cervical dilation >4cm

  • +6 more secondary outcomes

Study Arms (2)

I

ACTIVE COMPARATOR

Active phrase analgesia

Procedure: Active phrase epidural analgesia

II

ACTIVE COMPARATOR

Latent phrase analgesia

Procedure: Latent phrase epidural analgesia

Interventions

Active phrase epidural analgesiaPROCEDURE

Continuous epidural analgesia with sufentanil plus ropivacaine

I
Latent phrase epidural analgesiaPROCEDURE

Continuous epidural analgesia with sufentanil plus ropivacaine

II

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparas
  • Required labor analgesia
  • Chinese.

You may not qualify if:

  • Allergic to opioids and/or local anesthetics
  • Failed to performing epidural catheterization
  • Organic dysfunction
  • Contraindications for epidural analgesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

Related Publications (1)

  • Wang F, Shen X, Guo X, Peng Y, Gu X; Labor Analgesia Examining Group. Epidural analgesia in the latent phase of labor and the risk of cesarean delivery: a five-year randomized controlled trial. Anesthesiology. 2009 Oct;111(4):871-80. doi: 10.1097/ALN.0b013e3181b55e65.

    PMID: 19741492RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

January 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

CN(1)