Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women

Labor Pain Clinical Trial

— DCLEAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664118
• Other study ID #: NMCHCH-0121-236
• Secondary ID: NMUC-08022
• Status: Completed
• Phase: N/A
• First received: April 18, 2008
• Last updated: May 26, 2009
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• Doula combined analgesia
Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas
• Analgesia without doula
Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cesarean delivery		Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)	Yes
Secondary	Rate of instrumental delivery		Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)	Yes
Secondary	Indications of cesarean delivery		Analgesia initiation (0 h) to cesarean section (4-7 h)	Yes
Secondary	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	Yes
Secondary	Incidence of side effects		The whole period of the analgesia to successful vaginal delivery	Yes
Secondary	Low back pain at 3 months after vaginal delivery		Three months after vaginal delivery	Yes
Secondary	Maternal oral temperature		The whole period of the analgesia to successful vaginal delivery	Yes
Secondary	Use of oxytocin after analgesia		During the whole period of the analgesia	Yes
Secondary	Maximal oxytocin dose		30 min after vaginal delivery	Yes
Secondary	Duration of analgesia		Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)	Yes
Secondary	Breastfeeding success at 6 weeks after vaginal delivery		Six weeks after successful delivery	Yes
Secondary	Maternal satisfaction with analgesia		30 min after the vaginal delivery	No
Secondary	Neonatal one-minute Apgar scale		One minute after baby was born	Yes
Secondary	Neonatal five-minute Apgar scale		Five minutes after baby was born	Yes
Secondary	Umbilical-cord gases analysis		Immediately after baby was born	No
Secondary	Neonatal sepsis evaluation		5 min after the baby was born	Yes
Secondary	Neonatal antibiotic treatment		5 min after the baby was born	Yes