Effect of Doula in Nulliparas and Multiparas - Full Text View

Sponsored by:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00755092

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	150
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Doula for Nulliparous women	Behavioral: Doula Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
2: Active Comparator 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

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

Contacts

Contact: FuZhou Wang, MD	86-25-84460777 ext 3301	zfwang50@gmail.com
Contact: ShiQin Xu, MD	86-25-84460777 ext 3301	xusqnj@sina.com

Locations

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital	Recruiting
Nanjing, Jiangsu, China, 210004
Contact: YuZhu Peng, MD 86-25-8446-0777 ext 1508 pyz1131@hotmail.com
Contact: XiRong Guo, MD 86-25-8446-0777 ext 1508 xrguonjmueducn@yahoo.com.cn
Sub-Investigator: YuSheng Liu, MD

Sponsors and Collaborators

Nanjing Medical University

Investigators

Principal Investigator:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NMU-FY2008-416, NJFY-MZ08092
Study First Received:	September 17, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00755092
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Doula
Psychological care
Labor analgesia

Study placed in the following topic categories:

Signs and Symptoms
Labor Pain
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009