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Effect of Doula in Nulliparas and Multiparas (DINAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755092
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : February 11, 2009
Sponsor:
Information provided by:
Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE September 17, 2008
First Posted Date  ICMJE September 18, 2008
Last Update Posted Date February 11, 2009
Study Start Date  ICMJE September 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
VAS pain intensity [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
  • Ramsey sedative scale [ Time Frame: 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 ]
  • Vital signs [ Time Frame: 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 ]
  • Infant outcomes [ Time Frame: The time of delivery to 1 h after delivery ]
  • Cesarean rate [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Doula in Nulliparas and Multiparas
Official Title  ICMJE Analgesic Efficacy of Doula in Nulliparous and Multiparous Women
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Labor Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Doula for Nulliparous women
    Intervention: Behavioral: Doula
  • Active Comparator: 2
    Doula for Multiparous women
    Intervention: Behavioral: Doula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2008)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00755092
Other Study ID Numbers  ICMJE NMU-FY2008-416
NJFY-MZ08092
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party XiaoFeng Shen, Nanjing Medical University
Study Sponsor  ICMJE Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: XiaoFeng Shen, MD Nanjing Medical University
PRS Account Nanjing Medical University
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP