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NCT00127361 Clinical Trial

Study of Having a Female Friend as Labor Support

Pregnancy Clinical Trial

Official title:
Evaluation of Continuous Support in Labor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00127361
Other study ID # DAC-1998
Secondary ID
Status Completed
Phase N/A
First received August 4, 2005
Last updated August 22, 2005
Start date January 1998
Est. completion date February 2003

Study information
Verified date April 2005
Source Saint Peters University Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.

Description:

The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date February 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 45 Years
Eligibility Inclusion Criteria:

- Nulliparous (never given birth before)

- Singleton pregnancy

- Vertex presentation

- Low risk pregnancy

- Has a female friend willing to be a doula

Exclusion Criteria:

- Placenta previa

- Abruptio placenta

- Multiple pregnancy

- Breech presentation

- Planned operative delivery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• doula training

Locations
Country Name City State
United States Saint Peters University Hospital New Brunswick New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Saint Peters University Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of labor
Primary type of delivery
Primary type and timing of analgesia/anesthesia
Secondary Birthweight
Secondary neonatal Apgar score at 1 and 5 minutes after birth
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