Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women

NCT ID: NCT00664118

Last Updated: 2009-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-05-31

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Doula combined analgesia

Intervention Type: PROCEDURE

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

2

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

Group Type: SHAM_COMPARATOR

Analgesia without doula

Intervention Type: PROCEDURE

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

Interventions

Doula combined analgesia

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

Intervention Type: PROCEDURE

Analgesia without doula

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HRSA/Maternal and Child Health Bureau

FED

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nanjing Medical University

Principal Investigators

XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NMUC-08022

Identifier Type: -

Identifier Source: secondary_id

NMCHCH-0121-236

Identifier Type: -

Identifier Source: org_study_id