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

Cumulating evidence indicated that neuraxial analgesia in the latent phrase 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

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

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

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

Rate of cesarean delivery [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rate of instrumental delivery [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]
Indications of cesarean delivery [ Time Frame: Analgesia initiation to cesarean section ] [ Designated as safety issue: Yes ]
Maternal Visual Analog Scale (VAS) rating of pain [ Time Frame: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to delivery ] [ Designated as safety issue: Yes ]
Incidence of side effects [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]
Low back pain at 3 months after vaginal delivery [ Time Frame: At the third month after vaginal delivery ] [ Designated as safety issue: Yes ]
Maternal oral temperature [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]
Use of oxytocin after analgesia [ Time Frame: After analgesia to vaginal delivery ] [ Designated as safety issue: Yes ]
Maximal oxytocin dose [ Time Frame: At the end of vaginal delivery ] [ Designated as safety issue: Yes ]
Duration of analgesia [ Time Frame: Initiation of analgesia to the disappearance of sensory block ] [ Designated as safety issue: Yes ]
Breastfeeding success at 6 weeks after vaginal delivery [ Time Frame: At the sixth week after successful delivery ] [ Designated as safety issue: Yes ]
Maternal satisfaction with analgesia [ Time Frame: At the end of the vaginal delivery ] [ Designated as safety issue: No ]
Neonatal one-minute Apgar scale [ Time Frame: At the first minute of baby was born ] [ Designated as safety issue: Yes ]
Neonatal five-minute Apgar scale [ Time Frame: At the fifth minute of baby was born ] [ Designated as safety issue: Yes ]
Umbilical-cord gases analysis [ Time Frame: At the time baby was born ] [ Designated as safety issue: No ]
Neonatal sepsis evaluation [ Time Frame: After the baby was born ] [ Designated as safety issue: Yes ]
Neonatal antibiotic treatment [ Time Frame: After the baby was born ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	April 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Doula combined epidural analgesia in the latent phrase of first stage of labor	Procedure: Doula combined analgesia Doula combined epidural analgesia in the latent phrase of first stage of labor in primiparas
2: Sham Comparator Epidural analgesia in the latent phrase of the first stage of labor without doula accompany	Procedure: Analgesia without doula Epidural analgesia in the latent phrase 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
>18years and <45years
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 4.0cm or greater before performing epidural puncture and catheterization

Contacts and Locations

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

Contacts

Contact: FuZhou Wang, MD, MPH	86-25-8446-0777 ext 3301	zfwang50@gmail.com
Contact: ShiQin Xu, MD	86-25-8446-0777 ext 3301	xusqnj@sina.com

Locations

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital	Recruiting
Nanjing, Jiangsu, China, 210004
Contact: YuZhu Peng, MD 86-25-8347-5214 pyz1131@hotmail.com
Contact: XiRong Guo, MD 86-25-8347-5214 ext 1508 xrguonjmueducn@yahoo.com.cn
Sub-Investigator: YuSheng Liu, MD

Sponsors and Collaborators

Nanjing Medical University

HRSA/Maternal and Child Health Bureau

Investigators

Study Director:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NMCHCH-0121-236, NMUC-08022
Study First Received:	April 18, 2008
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00664118
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:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009