Effect of Doula in Nulliparas and Multiparas (DINAM)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00755092
First received: September 17, 2008
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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 Intervention
Labor Pain
Behavioral: Doula

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesic Efficacy of Doula in Nulliparous and Multiparous Women

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • VAS pain intensity [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ramsey sedative scale [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: From the beginning of regular contraction of uterus to the end of delivery ] [ Designated as safety issue: Yes ]
  • Infant outcomes [ Time Frame: The time of delivery to 1 h after delivery ] [ Designated as safety issue: Yes ]
  • Cesarean rate [ Time Frame: During the whole period of laboring ] [ Designated as safety issue: Yes ]
  • Overall feeling of satisfaction of analgesia [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755092

Locations
China, Jiangsu
Nanjing Medical University
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Principal Investigator: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00755092     History of Changes
Other Study ID Numbers: NMU-FY2008-416, NJFY-MZ08092
Study First Received: September 17, 2008
Last Updated: February 10, 2009
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Doula
Psychological care
Labor analgesia

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014