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Effect of Doula in Nulliparas and Multiparas (DINAM)

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Doula
Doula
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Doula, Psychological care, Labor analgesia

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Doula for Nulliparous women

Doula for Multiparous women

Outcomes

Primary Outcome Measures

VAS pain intensity

Secondary Outcome Measures

Ramsey sedative scale
Blood levels of corticosteroid
Vital signs
Adverse events
Infant outcomes
Cesarean rate
Overall feeling of satisfaction of analgesia

Full Information

First Posted
September 17, 2008
Last Updated
February 10, 2009
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00755092
Brief Title
Effect of Doula in Nulliparas and Multiparas
Acronym
DINAM
Official Title
Analgesic Efficacy of Doula in Nulliparous and Multiparous Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Doula, Psychological care, Labor analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Doula for Nulliparous women
Arm Title
2
Arm Type
Active Comparator
Arm Description
Doula for Multiparous women
Intervention Type
Behavioral
Intervention Name(s)
Doula
Intervention Description
Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
Intervention Type
Behavioral
Intervention Name(s)
Doula
Intervention Description
Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery
Primary Outcome Measure Information:
Title
VAS pain intensity
Time Frame
From the beginning of regular contraction of uterus to the end of delivery
Secondary Outcome Measure Information:
Title
Ramsey sedative scale
Time Frame
From the beginning of regular contraction of uterus to the end of delivery
Title
Blood levels of corticosteroid
Time Frame
10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery
Title
Vital signs
Time Frame
From the beginning of regular contraction of uterus to the end of delivery
Title
Adverse events
Time Frame
From the beginning of regular contraction of uterus to the end of delivery
Title
Infant outcomes
Time Frame
The time of delivery to 1 h after delivery
Title
Cesarean rate
Time Frame
During the whole period of laboring
Title
Overall feeling of satisfaction of analgesia
Time Frame
From the beginning of regular contraction of uterus to the end of the labor

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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Effect of Doula in Nulliparas and Multiparas

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