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

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00664118
First received: April 18, 2008
Last updated: May 26, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Labor Pain
Procedure: Doula combined analgesia
Procedure: Analgesia without doula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Rate of cesarean delivery [ Time Frame: Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of instrumental delivery [ Time Frame: Analgesia initiation (0 h) to successful vaginal delivery (4-7 h) ] [ Designated as safety issue: Yes ]
  • Indications of cesarean delivery [ Time Frame: Analgesia initiation (0 h) to cesarean section (4-7 h) ] [ Designated as safety issue: Yes ]
  • Maternal Visual Analog Scale (VAS) rating of pain [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Incidence of side effects [ Time Frame: The whole period of the analgesia to successful vaginal delivery ] [ Designated as safety issue: Yes ]
  • Low back pain at 3 months after vaginal delivery [ Time Frame: Three months after vaginal delivery ] [ Designated as safety issue: Yes ]
  • Maternal oral temperature [ Time Frame: The whole period of the analgesia to successful vaginal delivery ] [ Designated as safety issue: Yes ]
  • Use of oxytocin after analgesia [ Time Frame: During the whole period of the analgesia ] [ Designated as safety issue: Yes ]
  • Maximal oxytocin dose [ Time Frame: 30 min after vaginal delivery ] [ Designated as safety issue: Yes ]
  • Duration of analgesia [ Time Frame: Initiation of analgesia (0h) to the disappearance of sensory block (4-8h) ] [ Designated as safety issue: Yes ]
  • Breastfeeding success at 6 weeks after vaginal delivery [ Time Frame: Six weeks after successful delivery ] [ Designated as safety issue: Yes ]
  • Maternal satisfaction with analgesia [ Time Frame: 30 min after the vaginal delivery ] [ Designated as safety issue: No ]
  • Neonatal one-minute Apgar scale [ Time Frame: One minute after baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal five-minute Apgar scale [ Time Frame: Five minutes after baby was born ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: Immediately after baby was born ] [ Designated as safety issue: No ]
  • Neonatal sepsis evaluation [ Time Frame: 5 min after the baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: 5 min after the baby was born ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664118

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00664118     History of Changes
Other Study ID Numbers: NMCHCH-0121-236, NMUC-08022
Study First Received: April 18, 2008
Last Updated: May 26, 2009
Health Authority: China: Ministry of Health

Keywords provided by Nanjing Medical University:
Doula
Patient-controlled epidural analgesia
Neuraxial analgesia
Labor analgesia

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014