Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women - Full Text View

Sponsors and Collaborators:	Nanjing Medical University HRSA/Maternal and Child Health Bureau
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00664118

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:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

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
1: Active Comparator 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
2: Sham Comparator 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

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

Keywords provided by Nanjing Medical University:

Doula
Patient-controlled epidural analgesia
Neuraxial analgesia
Labor analgesia

Study placed in the following topic categories:

Signs and Symptoms
Labor Pain
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Labor Pain
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on September 11, 2009