NCT00664118

Brief Summary

Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

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

April 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 27, 2009

Status Verified

May 1, 2009

Enrollment Period

1.1 years

First QC Date

April 18, 2008

Last Update Submit

May 26, 2009

Conditions

Labor Pain

Keywords

DoulaPatient-controlled epidural analgesiaNeuraxial analgesiaLabor analgesia

Outcome Measures

Primary Outcomes (1)

  • Rate of cesarean delivery

    Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)

Secondary Outcomes (16)

  • Rate of instrumental delivery

    Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)

  • Indications of cesarean delivery

    Analgesia initiation (0 h) to cesarean section (4-7 h)

  • Maternal Visual Analog Scale (VAS) rating of pain

    15 min prior to analgesia, 0-3 h of the latent phrase, 2-3 h of the active phrase, 1-2 h of the second stage of labor, 15 min posterior to delivery

  • Incidence of side effects

    The whole period of the analgesia to successful vaginal delivery

  • Low back pain at 3 months after vaginal delivery

    Three months after vaginal delivery

  • +11 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Doula combined epidural analgesia in the latent phase of first stage of labor

Procedure: Doula combined analgesia

2

SHAM COMPARATOR

Epidural analgesia in the latent phase of the first stage of labor without doula accompany

Procedure: Analgesia without doula

Interventions

Doula combined analgesiaPROCEDURE

Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas

1
Analgesia without doulaPROCEDURE

Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas

2

Eligibility Criteria

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

You may qualify if:

  • Nulliparous women
  • \> 18 years and \< 45 years
  • Spontaneous labor
  • Analgesia request

You may not qualify if:

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors;
  • Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
  • Subjects with a nonvertex presentation or scheduled induction of labor
  • Cervical dilation was 4.0 cm or greater before performing epidural puncture and catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Labor Pain

Interventions

AnalgesiaDoulas

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 27, 2009

Record last verified: 2009-05

Locations

CN(1)