Effect of Doula in Nulliparas and Multiparas

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Behavioral: Doula

• Registration Number: NCT00755092
• Lead Sponsor: Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-10
• Last Update Posted: 2009-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Doula	Doula for Nulliparous women
2	Doula	Doula for Multiparous women

Primary Outcome Measures

Name	Time	Method
VAS pain intensity	From the beginning of regular contraction of uterus to the end of delivery

Secondary Outcome Measures

Name	Time	Method
Ramsey sedative scale	From the beginning of regular contraction of uterus to the end of delivery
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
Vital signs	From the beginning of regular contraction of uterus to the end of delivery
Adverse events	From the beginning of regular contraction of uterus to the end of delivery
Infant outcomes	The time of delivery to 1 h after delivery
Cesarean rate	During the whole period of laboring
Overall feeling of satisfaction of analgesia	From the beginning of regular contraction of uterus to the end of the labor

Trial Locations

Locations (1)

Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China