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Effect of Doula in Nulliparas and Multiparas (DINAM)

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Labor Pain Behavioral: Doula Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesic Efficacy of Doula in Nulliparous and Multiparous Women
Study Start Date : September 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009
Arms and Interventions
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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
Active Comparator: 2
Doula for Multiparous women
 Behavioral: Doula
Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery


Outcome Measures
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Primary Outcome Measures :
  1. VAS pain intensity [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ]

Secondary Outcome Measures :
  1. Ramsey sedative scale [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ]
  2. 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 ]
  3. Vital signs [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ]
  4. Adverse events [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ]
  5. Infant outcomes [ Time Frame: The time of delivery to 1 h after delivery ]
  6. Cesarean rate [ Time Frame: During the whole period of laboring ]
  7. Overall feeling of satisfaction of analgesia [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755092


Locations
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China, Jiangsu
Nanjing Medical University
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Principal Investigator: XiaoFeng Shen, MD Nanjing Medical University
More Information
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Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00755092    
Other Study ID Numbers: NMU-FY2008-416
NJFY-MZ08092
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by Nanjing Medical University:
Doula
Psychological care
Labor analgesia
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations