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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00755092
Other study ID # NMU-FY2008-416
Secondary ID NJFY-MZ08092
Status Completed
Phase N/A
First received September 17, 2008
Last updated February 10, 2009
Start date September 2008
Est. completion date January 2009

Study information

Verified date February 2009
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 45 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Doula
Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
Doula
Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery

Locations

Country Name City State
China Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAS pain intensity From the beginning of regular contraction of uterus to the end of delivery Yes
Secondary Ramsey sedative scale From the beginning of regular contraction of uterus to the end of delivery Yes
Secondary Blood levels of corticosteroid 10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery No
Secondary Vital signs From the beginning of regular contraction of uterus to the end of delivery Yes
Secondary Adverse events From the beginning of regular contraction of uterus to the end of delivery Yes
Secondary Infant outcomes The time of delivery to 1 h after delivery Yes
Secondary Cesarean rate During the whole period of laboring Yes
Secondary Overall feeling of satisfaction of analgesia From the beginning of regular contraction of uterus to the end of the labor No
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