Effect of Doula in Nulliparas and Multiparas

Labor Pain Clinical Trial

— DINAM  

Official title:

Analgesic Efficacy of Doula in Nulliparous and Multiparous Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755092
• Other study ID #: NMU-FY2008-416
• Secondary ID: NJFY-MZ08092
• Status: Completed
• Phase: N/A
• First received: September 17, 2008
• Last updated: February 10, 2009
• Start date: September 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Psychological care during labor is considered as an important supplemental procedure for alleviating delivering stress and pain. Although Doula has been recommending that should be given for parturients, its precise effect on nulliparous and multiparous women is still unknown. The investigators hypothesized that multiparas had experienced the process of labor, but the nulliparas were not, so Doula support would produce different effect on these two population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy term parturients

• Chinese

• 19-45 years

Exclusion Criteria:

• Organic dysfunction

• Participants younger than 19 years or older than 45 years

• Those who were not willing to or could not finish the whole study at any time

• Pregnancy-induced hypertension and diabetes mellitus

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Labor Pain

Intervention

Behavioral:
• Doula
Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
• Doula
Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery

Locations

Country	Name	City	State
China	Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain intensity		From the beginning of regular contraction of uterus to the end of delivery	Yes
Secondary	Ramsey sedative scale		From the beginning of regular contraction of uterus to the end of delivery	Yes
Secondary	Blood levels of corticosteroid		10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery	No
Secondary	Vital signs		From the beginning of regular contraction of uterus to the end of delivery	Yes
Secondary	Adverse events		From the beginning of regular contraction of uterus to the end of delivery	Yes
Secondary	Infant outcomes		The time of delivery to 1 h after delivery	Yes
Secondary	Cesarean rate		During the whole period of laboring	Yes
Secondary	Overall feeling of satisfaction of analgesia		From the beginning of regular contraction of uterus to the end of the labor	No