Study of Having a Female Friend as Labor Support

Not Applicable

Completed

• Conditions: Pregnancy; Delivery, Obstetric

• Registration Number: NCT00127361
• Lead Sponsor: Saint Peters University Hospital

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 1998-01
• Study Completion: 2003-02
• Status Verified: 2005-04
• Study First Submitted: 2005-08-04
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-05
• Last Update Submitted: 2005-08-22
• Last Update Posted: 2005-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Length of labor
type of delivery
type and timing of analgesia/anesthesia

Secondary Outcome Measures

Name	Time	Method
Birthweight
neonatal Apgar score at 1 and 5 minutes after birth

Trial Locations

Locations (1)

Saint Peters University Hospital; 🇺🇸 New Brunswick, New Jersey, United States