Effect of Doula in Nulliparas and Multiparas (DINAM)

February 10, 2009 updated by: Nanjing Medical University

Analgesic Efficacy of Doula in Nulliparous and Multiparous Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Doula for Nulliparous women
Behavioral: Doula
Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
Behavioral: Doula
Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery
Active Comparator: 2
Doula for Multiparous women
Behavioral: Doula
Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
Behavioral: Doula
Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS pain intensity
Time Frame: From the beginning of regular contraction of uterus to the end of delivery
From the beginning of regular contraction of uterus to the end of delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Ramsey sedative scale
Time Frame: From the beginning of regular contraction of uterus to the end of delivery
From the beginning of regular contraction of uterus to the end of delivery
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
10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery
Vital signs
Time Frame: From the beginning of regular contraction of uterus to the end of delivery
From the beginning of regular contraction of uterus to the end of delivery
Adverse events
Time Frame: From the beginning of regular contraction of uterus to the end of delivery
From the beginning of regular contraction of uterus to the end of delivery
Infant outcomes
Time Frame: The time of delivery to 1 h after delivery
The time of delivery to 1 h after delivery
Cesarean rate
Time Frame: During the whole period of laboring
During the whole period of laboring
Overall feeling of satisfaction of analgesia
Time Frame: From the beginning of regular contraction of uterus to the end of the labor
From the beginning of regular contraction of uterus to the end of the labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Investigators

  • Principal Investigator: XiaoFeng Shen, MD, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2009

Last Update Submitted That Met QC Criteria

February 10, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-FY2008-416
  • NJFY-MZ08092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe