Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women (DCLEAP)

In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Procedure: Doula combined analgesia; Procedure: Analgesia without doula

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Doula combined epidural analgesia in the latent phase of first stage of labor	Procedure: Doula combined analgesia; Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas
Sham Comparator: 2; Epidural analgesia in the latent phase of the first stage of labor without doula accompany	Procedure: Analgesia without doula; Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of cesarean delivery	Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Maternal oral temperature	The whole period of the analgesia to successful vaginal delivery
Use of oxytocin after analgesia	During the whole period of the analgesia
Maximal oxytocin dose	30 min after vaginal delivery
Duration of analgesia	Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)
Breastfeeding success at 6 weeks after vaginal delivery	Six weeks after successful delivery
Maternal satisfaction with analgesia	30 min after the vaginal delivery
Neonatal one-minute Apgar scale	One minute after baby was born
Neonatal five-minute Apgar scale	Five minutes after baby was born
Umbilical-cord gases analysis	Immediately after baby was born
Neonatal sepsis evaluation	5 min after the baby was born
Neonatal antibiotic treatment	5 min after the baby was born

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: HRSA/Maternal and Child Health Bureau

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): May 27, 2009
• Last Update Submitted That Met QC Criteria: May 26, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Labor analgesia; Neuraxial analgesia; Doula; Patient-controlled epidural analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: NMCHCH-0121-236; NMUC-08022